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| ID | Type | Description | Link |
|---|---|---|---|
| N01CN35160 | U.S. NIH Grant/Contract | View source | |
| CDR0000558657 | Registry Identifier | PDQ (Physician Data Query) | |
| UCI04-3-01 | Other Grant/Funding Number | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase II trial studies how well S-Adenosyl-L-Methionine Disulphate P-Toluene-Sulfonate (SAMe) works compared to a placebo in preventing liver cancer in patients with chronic hepatitis C infection. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of SAMe may keep cancer from forming in patients with advanced liver disease
PRIMARY OBJECTIVE:
I. To determine whether treatment with SAMe for 24 weeks reduces serum level of alpha-fetoprotein (AFP) in patients with advanced liver disease due to chronic hepatitis C.
SECONDARY OBJECTIVE:
I. To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) and alpha-fetoprotein-L3 (AFP-L3) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).
II. To determine whether treatment with SAMe for 24 weeks alters biochemical markers of liver disease (e.g., serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], albumin, or bilirubin, etc.) and hepatitis C viral load in patients with advanced liver disease due to chronic hepatitis C (hepatitis C liver disease).
III. To determine whether treatment with SAMe for 24 weeks reduces serum levels of tumor necrosis factor-alpha (TNF-alpha), plasma levels of malondialdehyde (MDA), 4-hydroxynonenal (4-HNE) and urine levels of F2-isoprostane in patients with advanced liver disease due to chronic hepatitis C (oxidative stress).
IV. To determine whether treatment with SAMe for 24 weeks reduces plasma levels of methionine and homocysteine and increases plasma glutathione (GSH) and SAMe in patients with advanced liver disease due to chronic hepatitis C (SAMe metabolites).
V. To determine the safety, tolerability and quality of life of SAMe treatment (up to 2,400 mg/day) for 24 weeks in patients with advanced liver disease due to chronic hepatitis C.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive SAMe orally (PO) twice daily (BID) for 24 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO once daily (QD) for weeks 1-4, PO BID for weeks 5-8, and PO three times daily (TID) for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (SAMe) | Experimental | Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-adenosyl-L-methionine disulfate p-toluene-sulfonate | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum AFP Levels | Measured using an Food and Drug Administration (FDA)-approved assay. Mean change over time for the SAMe and placebo groups will be estimated. Differences in the change over time between the treated and control groups will be tested using a two-group repeated measures analysis of variance model. | Baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma | To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers). | Baseline to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hoefs | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Health Sciences Center | Tucson | Arizona | 85724 | United States | ||
| Veterans Administration Long Beach Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26130251 | Result | Morgan TR, Osann K, Bottiglieri T, Pimstone N, Hoefs JC, Hu KQ, Hassanein T, Boyer TD, Kong L, Chen WP, Richmond E, Gonzalez R, Rodriguez LM, Meyskens FL. A Phase II Randomized, Controlled Trial of S-Adenosylmethionine in Reducing Serum alpha-Fetoprotein in Patients with Hepatitis C Cirrhosis and Elevated AFP. Cancer Prev Res (Phila). 2015 Sep;8(9):864-72. doi: 10.1158/1940-6207.CAPR-15-0029. Epub 2015 Jun 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (SAMe) | Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity. S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO laboratory biomarker analysis: Correlative studies immunoenzyme technique: Correlative studies high performance liquid chromatography: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Other | Given PO |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| immunoenzyme technique | Other | Correlative studies |
|
|
| high performance liquid chromatography | Other | Correlative studies |
|
|
| Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma |
AFP-L3 assay will be performed by Wako Laboratories using their LiBASys platform. |
| Baseline to week 24 |
| SAMe | Change in SAMe levels | Baseline to week 24 |
| Change in SAMe Metabolites - S-adenosylhomocysteine (SAH) | S-adenosylhomocysteine (SAH) | Baseline to week 24 |
| Change in SAMe Metabolites - Methionine | Methionine will be measured using HPLC with fluorescence detection. | Baseline to week 24 |
| Change in SAMe Metabolites - Total Homocysteine (tHcy) | Total homocysteine (tHcy) | Baseline to week 24 |
| Change in SAMe Metabolites - Plasma GSH | Plasma GSH will be measured using HPLC with fluorescence detection. | Baseline to week 24 |
| Change in SAMe Metabolites - Malondialdehyde (MDA) | malondialdehyde | Baseline to week 24 |
| Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE) | Serum marker of oxidative stress. One mechanism by which SAMe is hypothesized to be beneficial is by reducing oxidative stress. | Baseline to week 24 |
| Change in Markers of Liver Disease - AST | AST measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays. | Baseline to week 24 |
| Change in Markers of Liver Disease - ALT | ALT measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays. | Baseline to week 24 |
| HCV RNA | Change in HCV RNA levels. Serum level of HVC RNA was measured using COBAS TaqMan HCV test (Roche Molecular Systems). | Baseline to week 24 |
| Changes in Quality of Life - Physical Score | Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Physical Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change in QOL = (Week 24 score - Baseline score). | Baseline to week 24 |
| Changes in Quality of Life - Mental Score | Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Mental Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change = (Week 24 score - Baseline score). | Baseline to week 24 |
| Long Beach |
| California |
| 90822 |
| United States |
| Veterans Administration Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| University of California At San Diego | San Diego | California | 92103 | United States |
| FG001 | Arm II (Placebo) | Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity. placebo: Given PO laboratory biomarker analysis: Correlative studies immunoenzyme technique: Correlative studies high performance liquid chromatography: Correlative studies |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (SAMe) | Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity. S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO laboratory biomarker analysis: Correlative studies immunoenzyme technique: Correlative studies high performance liquid chromatography: Correlative studies |
| BG001 | Arm II (Placebo) | Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity. placebo: Given PO laboratory biomarker analysis: Correlative studies immunoenzyme technique: Correlative studies high performance liquid chromatography: Correlative studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum AFP Levels | Measured using an Food and Drug Administration (FDA)-approved assay. Mean change over time for the SAMe and placebo groups will be estimated. Differences in the change over time between the treated and control groups will be tested using a two-group repeated measures analysis of variance model. | All subjects who completed the week 24 visit as planned were included in the data anlysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | ng/mL | Baseline to week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma | To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers). | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | ng/mL | Baseline to week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma | AFP-L3 assay will be performed by Wako Laboratories using their LiBASys platform. | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | percentage of AFP-L3/AFP | Baseline to week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SAMe | Change in SAMe levels | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | nmol/L | Baseline to week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SAMe Metabolites - S-adenosylhomocysteine (SAH) | S-adenosylhomocysteine (SAH) | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | nmol/L | Baseline to week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SAMe Metabolites - Methionine | Methionine will be measured using HPLC with fluorescence detection. | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | µmol/L | Baseline to week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SAMe Metabolites - Total Homocysteine (tHcy) | Total homocysteine (tHcy) | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | µmol/L | Baseline to week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SAMe Metabolites - Plasma GSH | Plasma GSH will be measured using HPLC with fluorescence detection. | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | µmol/L | Baseline to week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SAMe Metabolites - Malondialdehyde (MDA) | malondialdehyde | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | µmol/L | Baseline to week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE) | Serum marker of oxidative stress. One mechanism by which SAMe is hypothesized to be beneficial is by reducing oxidative stress. | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | µg/mL | Baseline to week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Markers of Liver Disease - AST | AST measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays. | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | IU/L | Baseline to week 24 |
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| Secondary | Change in Markers of Liver Disease - ALT | ALT measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays. | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | IU/L | Baseline to week 24 |
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| Secondary | HCV RNA | Change in HCV RNA levels. Serum level of HVC RNA was measured using COBAS TaqMan HCV test (Roche Molecular Systems). | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | IU/mL | Baseline to week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Quality of Life - Physical Score | Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Physical Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change in QOL = (Week 24 score - Baseline score). | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | units on a scale | Baseline to week 24 |
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| Secondary | Changes in Quality of Life - Mental Score | Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Mental Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change = (Week 24 score - Baseline score). | All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to week 24 |
|
Through study completion, an average of 30 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (SAMe) | Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity. S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO laboratory biomarker analysis: Correlative studies immunoenzyme technique: Correlative studies high performance liquid chromatography: Correlative studies | 5 | 57 | 51 | 57 | ||
| EG001 | Arm II (Placebo) | Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity. placebo: Given PO laboratory biomarker analysis: Correlative studies immunoenzyme technique: Correlative studies high performance liquid chromatography: Correlative studies | 3 | 53 | 46 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL CELLULITIS | Infections and infestations | Non-systematic Assessment |
| ||
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| ABDOMINAL PAIN.STATUS POST SPLENIC ARTERY EMBOLIZATION | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| ANGIOPLASTY OF LEFT HYPOGASTRIC ARTERY, EXTERNAL ILIAC STENT PLACEMENT FOR LEFT LEG | Vascular disorders | Non-systematic Assessment |
| ||
| HEPATOCELLULAR CARCINOMA | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| LEFT THIGH ABSCESS | Infections and infestations | Non-systematic Assessment |
| ||
| NEPHROTIC SYNDROME | Renal and urinary disorders | Non-systematic Assessment |
| ||
| NON-ST ELEVATION MIOCARDIAL INFARCTION | Cardiac disorders | Non-systematic Assessment |
| ||
| PNEUMONIA | Infections and infestations | Non-systematic Assessment |
| ||
| SMALL BOWEL INFLAMATION | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| SPLENOMEGALY SECONDARY TO PORTAL HYPERTENSION | Hepatobiliary disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL CRAMPS | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| ALLERGIC RHINITIS | Immune system disorders | Non-systematic Assessment |
| ||
| ANAL IRRITATION | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| ANXIETY | Psychiatric disorders | Non-systematic Assessment |
| ||
| ARTHRITIS PAIN, KNEES | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| ARTHRITIS PAIN, LOWER BACK | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| ASCITES | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| BAD GAS | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| BLACK OUT | Nervous system disorders | Non-systematic Assessment |
| ||
| BLEEDING ESPHAGEAL VARICES | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| BLOOD IN STOOLS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| BLURRED VISION | Eye disorders | Non-systematic Assessment |
| ||
| BORDERLINE DIABETES | Endocrine disorders | Non-systematic Assessment |
| ||
| BREAST TENDERNESS | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| BROKEN TOOTH-UNCOMPLICATED | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| BRONCHITIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| BRUISING R LEG | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| CELLULITIS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| CHEST CONGESTION | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| CHILLS | General disorders | Non-systematic Assessment |
| ||
| CHRONIC ASCITES | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| CHRONIC GASTRITIS | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| CLICKING SOUND IN THE HEAD | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| COLD | General disorders | Non-systematic Assessment |
| ||
| COMMON COLD | General disorders | Non-systematic Assessment |
| ||
| CONSTIPATION | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| COUGH | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| CYST ON PATELLA | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| DARK COLORED URINE | Renal and urinary disorders | Non-systematic Assessment |
| ||
| DECREASED INSOMNIA | Psychiatric disorders | Non-systematic Assessment |
| ||
| DENTAL IMPLANT SURGERY | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DEPRESSION | Psychiatric disorders | Non-systematic Assessment |
| ||
| DIABETES MELLITUS | Endocrine disorders | Non-systematic Assessment |
| ||
| DIARRHEA | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DIARRHEA 4-6 STOOLS/DAY | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DIFFUSE ABDOMINAL PAIN | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DISLOCATION OF LEFT SHOULDER | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| DIZZINESS | Nervous system disorders | Non-systematic Assessment |
| ||
| DRY MOUTH | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DRY MOUTH/SALIVARY GLAND | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DRYNESS OF MOUTH | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| EAR PAIN | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| EARS RINGING | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| ELEVATED AFP | Renal and urinary disorders | Non-systematic Assessment |
| ||
| ELEVATED CREATININE | Investigations | Non-systematic Assessment |
| ||
| ELEVATED INR | Investigations | Non-systematic Assessment |
| ||
| EXTRA GAS FLATULENCE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| EYE PAIN | Eye disorders | Non-systematic Assessment |
| ||
| EYES HURT | Eye disorders | Non-systematic Assessment |
| ||
| FACIAL SWELLING OF ALLERGIC ORIGIN | Immune system disorders | Non-systematic Assessment |
| ||
| FALL, HIP AND BACK PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| FATIGUE | General disorders | Non-systematic Assessment |
| ||
| FEET AND LEGS CRAMPS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| FEVER | General disorders | Non-systematic Assessment |
| ||
| FLATULENCE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| FLU | General disorders | Non-systematic Assessment |
| ||
| FLU-LIKE SYMPTOMS | General disorders | Non-systematic Assessment |
| ||
| FOOD POISONING | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| FORGETFULNESS | Nervous system disorders | Non-systematic Assessment |
| ||
| FRACTURE 5TH R METACARPAL | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| GAS-FLATULENCE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| GI CONSTIPATION | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| GUM BLEEDING | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| HAIR LOSS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| HAPPIER | Psychiatric disorders | Non-systematic Assessment |
| ||
| HEADACHE | Nervous system disorders | Non-systematic Assessment |
| ||
| HEADACHE-SINUS | Nervous system disorders | Non-systematic Assessment |
| ||
| HEARTBURN | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| HEPATIC ENCEPHALOPATHY | Nervous system disorders | Non-systematic Assessment |
| ||
| HOT FLUSHES | Endocrine disorders | Non-systematic Assessment |
| ||
| HUNGRIER | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| HYPERSOMNIA | Psychiatric disorders | Non-systematic Assessment |
| ||
| HYPOKALEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| INCREASE IN FLATULENCE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| INCREASE NUMBER OF STOOLS | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| INCREASE PEE | Renal and urinary disorders | Non-systematic Assessment |
| ||
| INCREASED DIARRHEA | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| INCREASED FLATULENCE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| INCREASED STOMACH PAIN | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| INCREASED SWEATING | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| INCREASED URINATION | Renal and urinary disorders | Non-systematic Assessment |
| ||
| INFECTED SEBACEOUS CYST R. AXILA | Infections and infestations | Non-systematic Assessment |
| ||
| INSOMNIA | Psychiatric disorders | Non-systematic Assessment |
| ||
| INTERMITTENT HEADACHE | Nervous system disorders | Non-systematic Assessment |
| ||
| INTESTINAL FLU | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| INVOLUNTARY MOVEMENT | Nervous system disorders | Non-systematic Assessment |
| ||
| IRRITABILITY | Psychiatric disorders | Non-systematic Assessment |
| ||
| ITCHINESS ALL OVER THE BODY | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| ITCHING | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| JOINT PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| KNEE PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| LEFT LEG VASCULAR CLAUDICATION | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| LEFT SIDE PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| LEG CRAMPS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| LOWER BACK PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| LOWER BACK SURGERY | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| LOWER BACKACHE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| LOWER EXTREMITY EDEMA | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| MACULOPAPULAR RASH ON TORSO | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| MANIA | Psychiatric disorders | Non-systematic Assessment |
| ||
| MEMORY LOSS | Nervous system disorders | Non-systematic Assessment |
| ||
| MILD RASH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| MOOD ALTERATION | Psychiatric disorders | Non-systematic Assessment |
| ||
| MOOD ALTERATION DEPRESSION | Psychiatric disorders | Non-systematic Assessment |
| ||
| MOOD ALTERATION-ANXIETY | Psychiatric disorders | Non-systematic Assessment |
| ||
| MOOD ALTERATION-HAPPY | Psychiatric disorders | Non-systematic Assessment |
| ||
| MOOD ALTERATION:ANXIETY | Psychiatric disorders | Non-systematic Assessment |
| ||
| MUSCLE CRAMPS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| MUSCLE CRAMPS OF BOTH LEGS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| MUSCLE MOVEMENT | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| MUSCULOSKELETAL PAIN (NECK) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| MYALGIA | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| NECK PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| NOSE BLEEDING | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| OLECRANON BURSITIS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| PAIN IN BOTH HANDS AND FEET | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| PAIN IN KNEE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| PAIN LEFT SIDE OF CHEST | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| PAIN ON ANKLE JOINTS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| PAIN ON HIP | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| PAIN ON KNEE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| PINCHED NERVE | Nervous system disorders | Non-systematic Assessment |
| ||
| PNEUMONIA | Infections and infestations | Non-systematic Assessment |
| ||
| QUEASINESS | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| RASH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RASH ON BOTH ARMS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RASH ON EXTREMETIES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RESPIRATORY TRACT INFECTION | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| RESTLESSNESS | Psychiatric disorders | Non-systematic Assessment |
| ||
| SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| SINUS PAIN | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| SINUSITIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| SKIN RASH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| SPRAINED ANKLE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| STIFF NECK | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| STIFFNESS OF JOINTS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| STOMACH ACHE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| STOMACH CRAMPS | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| STOMACH FLU | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| STOMACH PAIN | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| SWEATING | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| SWEATING "NIGHT" | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| SWELLING OF ANKLES | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| TICS | Nervous system disorders | Non-systematic Assessment |
| ||
| TINNITUS | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| TIREDNESS FATIGUE | General disorders | Non-systematic Assessment |
| ||
| TOOTH EXTRACTION | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| TOOTHACHE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| ULCERATION OF THE LIP | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| UPSET STOMACH | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| URINE ODOR | Renal and urinary disorders | Non-systematic Assessment |
| ||
| VAGINAL IRRITATION | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| VAGINAL YEAST INFECTION | Infections and infestations | Non-systematic Assessment |
| ||
| VIRAL INFECTION INCLUDING COUGHING | Infections and infestations | Non-systematic Assessment |
| ||
| VITAMIN D DEFICIENCY | Investigations | Non-systematic Assessment |
| ||
| VIVID DREAMS | Psychiatric disorders | Non-systematic Assessment |
| ||
| VOMITING | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| WEAKNESS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| WEIGHT GAIN | Investigations | Non-systematic Assessment |
| ||
| WORSENING OF ANXIETY | Psychiatric disorders | Non-systematic Assessment |
| ||
| WORSENING OF BACK PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| WORSENING OF BASELINE DIABETES MELLITUS | Endocrine disorders | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timothy R. Morgan | University of California, Irvine | 562-826-5756 | timothy.morgan@va.gov |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
Not provided
Not provided
| ID | Term |
|---|---|
| D007124 | Immunoenzyme Techniques |
| D002851 | Chromatography, High Pressure Liquid |
| ID | Term |
|---|---|
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |
| D002853 | Chromatography, Liquid |
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
Not provided
Not provided
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