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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01631 | Other Identifier | NCI | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this study is to estimate the prevalence of HIV, Hepatitis B and hepatitis C infection among newly diagnosed cancer patients presenting to community and academic oncology clinics.
Primary Objective
Among newly diagnosed cancer patients presenting to SWOG-affiliated community and academic oncology clinics, estimate the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection. Prevalence estimates will be further stratified: by whether infection with the virus(es) is known, as reported by patients and/or their physician prior to study testing, vs. unknown; by presenting cancer type, and by self-reported risk factors for each virus.
Secondary Objectives
Tertiary Objective
Create a biorepository of stored serum for future translational medicine studies that may include identifying genomic and viral factors that increase the risk of serious adverse effects among participants infected with HIV, HBV, and/or HCV being treated for invasive cancers.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive Viral Infection | An estimate of the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection among newly diagnosed cancer participants presenting to SWOG-affiliated community and academic oncology clinics. | Up to 21 days after registration |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Important Risk Factors in Participants Tested for Previous HBV | The presence or absence of specific risk factors among participants evaluated for previous HBV is evaluated. | Up to 21 days after registration |
| Presence of Important Risk Factors in Participants Tested for Chronic HBV |
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Inclusion Criteria:
Patients who are viral positive for either HIV, HBV, and/or HCV and who do not wish to be retested are eligible, provided documentation of viral load within 120 days prior to registration can be obtained. Note that these patients must be tested for or provide current viral load for all three viruses to be eligible. Documentation must be obtained prior to registration.)
Exclusion Criteria:
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Community and academic oncology clinics
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| Name | Affiliation | Role |
|---|---|---|
| Scott D. Ramsey, M.D. | Fred Hutchinson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Hospital | Fontana | California | 92335 | United States | ||
| Kaiser Permanente - Harbor City |
3092 participants were screened for the trial; 41 were deemed ineligible and 3051 eligible participants were registered to the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | HBV, HCV, or HIV Prevalence | Participants received testing for at least one of the following, HBV, HCV, or HIV. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 27, 2017 |
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Specimen submission is optional.
The presence or absence of specific risk factors among participants evaluated for chronic HBV is evaluated. |
| Up to 21 days after registration |
| Presence of Important Risk Factors in Participants Tested for HCV | The presence or absence of specific risk factors among participants evaluated for HCV is evaluated. | Up to 21 days after registration |
| Presence of Important Risk Factors in Participants Tested for HIV | The presence or absence of specific risk factors among participants evaluated for HIV is evaluated. | Up to 21 days after registration |
| Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Among participants with HIV, HBV, or HCV, the timing and type of treatments received, both for the viral infections and the cancers that were evaluated. | 60 days after registration |
| Type and Rate of Adverse Events Among Patients With Viral Infection. | Estimate type and rate of cancer-treatment related adverse events among persons with HIV, HBV, and/or HCV infection. | 5 years after registration |
| Cost-effectiveness of Viral Screening | Estimate the cost-effectiveness of screening for HIV, HBV, and HCV. | 3 years after registration |
| Harbor City |
| California |
| 90710 |
| United States |
| Contra Costa Regional Medical Center | Martinez | California | 94553-3156 | United States |
| East Bay Physicians Medical Group-Summit | Oakland | California | 94609 | United States |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | United States |
| Desert Regional Medical Center | Palm Springs | California | 92262 | United States |
| Kaiser Permanente - Panorama City | Panorama City | California | 91402 | United States |
| Kaiser Permanente-Roseville | Roseville | California | 95661 | United States |
| Kaiser Permanente-San Francisco | San Francisco | California | 94115 | United States |
| Kaiser Permanente Medical Center-Vacaville | Vacaville | California | 95688 | United States |
| Kaiser Permanente-Lone Tree | Lone Tree | Colorado | 80124 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859 | United States |
| Saint Luke's Mountain States Tumor Institute - Meridian | Meridian | Idaho | 83642 | United States |
| Mac Neal Hospital | Berwyn | Illinois | 60402 | United States |
| Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| Hines Veterans Administration Hospital | Hines | Illinois | 60141 | United States |
| West Suburban Medical Center | River Forest | Illinois | 60305 | United States |
| Veteran Administration Eastern Kansas Healthcare | Leavenworth | Kansas | 66048 | United States |
| Topeka VA Hospital | Topeka | Kansas | 66622 | United States |
| LSU Health Baton Rouge-North Clinic | Baton Rouge | Louisiana | 70805 | United States |
| Louisiana Hematology Oncology Associates LLC | Baton Rouge | Louisiana | 70809 | United States |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | United States |
| Medical Oncology LLC | Baton Rouge | Louisiana | 70809 | United States |
| Mary Bird Cancer Center/Saint Tammany Parish | Covington | Louisiana | 70433 | United States |
| Women's Cancer Care-Covington | Covington | Louisiana | 70433 | United States |
| Mary Bird Perkins Cancer Center/Terrebonne General Medical Center | Houma | Louisiana | 70360 | United States |
| Oncology Center of The South Incorporated | Houma | Louisiana | 70360 | United States |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | United States |
| University Health-Conway | Monroe | Louisiana | 71202 | United States |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | United States |
| Louisiana State University Health Sciences Center Shreveport | Shreveport | Louisiana | 71103 | United States |
| North Shore Hematology Oncology Associates Inc | Slidell | Louisiana | 70458 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Kansas City Veterans Affairs Medical Center | Kansas City | Missouri | 64128 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | United States |
| Saint James Community Hospital and Cancer Treatment Center | Butte | Montana | 59701 | United States |
| Columbia University/Herbert Irving Cancer Center | New York | New York | 10032 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Columbus Oncology and Hematology Associates Inc | Columbus | Ohio | 43214 | United States |
| Grant Medical Center | Columbus | Ohio | 43215 | United States |
| OneHealth Marion General Hospital | Marion | Ohio | 43302 | United States |
| Knox Community Hospital | Mount Vernon | Ohio | 43050 | United States |
| Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Southern Ohio Medical Center | Portsmouth | Ohio | 45662 | United States |
| Kaiser Permanente Northwest | Portland | Oregon | 97227 | United States |
| Greenville Health System Cancer Institute-Andrews | Greenville | South Carolina | 29605 | United States |
| Greenville Health System Cancer Institute-Butternut | Greenville | South Carolina | 29605 | United States |
| Greenville Health System Cancer Institute-Faris | Greenville | South Carolina | 29605 | United States |
| Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina | 29615 | United States |
| Greenville Health System Cancer Institute-Greer | Greer | South Carolina | 29650 | United States |
| Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina | 29672 | United States |
| Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina | 29307 | United States |
| The Don and Sybil Harrington Cancer Center | Amarillo | Texas | 79106 | United States |
| Lyndon Baines Johnson General Hospital | Houston | Texas | 77026-1967 | United States |
| Audie L Murphy Veterans Affairs Hospital | San Antonio | Texas | 78209 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Evaluated for HBV Status |
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| Evaluated for HCV Status |
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| Evaluated for HIV Status |
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| COMPLETED |
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| NOT COMPLETED |
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This analysis population includes the 3051 participants that were eligible to receive at least one viral test.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Newly Diagnosed Cancer | Participants with newly diagnosed cancer that underwent viral testing for at least one of the following: HBV, HCV, and HIV. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Cancer Type | Count of Participants | Participants |
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| Region | Count of Participants | Participants |
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| 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 | Number of Participants With Positive Viral Infection | An estimate of the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection among newly diagnosed cancer participants presenting to SWOG-affiliated community and academic oncology clinics. | The analysis population includes the 3051 participants eligible to receive at least one viral test (for HBV, HCV, or HIV). 3050 participants were evaluable for HBV analysis (1 participants had no HBV test results available), 2990 participants were evaluable for HCV analysis (5 participants had no HCV test results available and 56 participants incomplete test results), and 3045 participants were evaluable for HIV analysis (6 participants had no HIV test results available). | Posted | Count of Participants | Participants | Up to 21 days after registration |
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| Secondary | Presence of Important Risk Factors in Participants Tested for Previous HBV | The presence or absence of specific risk factors among participants evaluated for previous HBV is evaluated. | The analysis population includes the 2940 of the 3050 participants who were evaluable for HBV analysis and completed the risk factor survey. | Posted | Count of Participants | Participants | Up to 21 days after registration |
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| Secondary | Presence of Important Risk Factors in Participants Tested for Chronic HBV | The presence or absence of specific risk factors among participants evaluated for chronic HBV is evaluated. | The analysis population includes the 2940 of the 3050 participants who were evaluable for HBV analysis and completed the risk factor survey. | Posted | Count of Participants | Participants | Up to 21 days after registration |
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| Secondary | Presence of Important Risk Factors in Participants Tested for HCV | The presence or absence of specific risk factors among participants evaluated for HCV is evaluated. | The analysis population includes the 2882 of the 2990 participants who were evaluable for HCV analysis completed the risk factor survey. | Posted | Count of Participants | Participants | Up to 21 days after registration |
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| Secondary | Presence of Important Risk Factors in Participants Tested for HIV | The presence or absence of specific risk factors among participants evaluated for HIV is evaluated. | The analysis population includes the 2934 of the 3045 participants were evaluable for HIV analysis and completed the risk factor survey. | Posted | Count of Participants | Participants | Up to 21 days after registration |
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| Secondary | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Among participants with HIV, HBV, or HCV, the timing and type of treatments received, both for the viral infections and the cancers that were evaluated. | The analysis population includes the 224 participants who were viral positive for at least one viral test (for HBV, HCV, or HIV) and had treatment outcome data available. Of the 292 patients were who were viral positive for at least one viral test, 11 patients did not have data submitted and 57 patients did not have data available. | Posted | Number | percentage of participants | 60 days after registration |
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| Secondary | Type and Rate of Adverse Events Among Patients With Viral Infection. | Estimate type and rate of cancer-treatment related adverse events among persons with HIV, HBV, and/or HCV infection. | Not Posted | 5 years after registration | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Cost-effectiveness of Viral Screening | Estimate the cost-effectiveness of screening for HIV, HBV, and HCV. | Not Posted | 3 years after registration | Participants |
Duration of study, 2 years.
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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 | HBV, HCV, or HIV Prevalence | Patients received testing for at least one of the following, HBV, HCV, or HIV, | 0 | 3,051 | 0 | 3,051 | 0 | 3,051 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cancer Care Delivery Committee Statistician | SWOG Statistics and Data Management Center | 2066674623 | karnold@fredhutch.org |
| Apr 21, 2023 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Unknown or Not Reported |
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| Asian |
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| Other |
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| Gastrointestinal tract, colorectal |
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| Gastrointestinal, liver |
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| Gastrointestinal, other |
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| Head and neck |
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| Lung |
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| Prostate |
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| Other |
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| Missing |
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| Positive Viral Test in Previously Diagnosed Participants |
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| Positive Viral Test in Newly Diagnosed Participants |
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| Positive Viral Test in Participants with Blood/Marrow Cancer |
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| Positive Viral Test in Participants with Breast Cancer |
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| Positive Viral Test in Participants with Colorectal Cancer |
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| Positive Viral Test in Participants with Liver Cancer |
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| Positive Viral Test in Participants with GI, Other Tract Cancer |
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| Positive Viral Test in Participants with Head and Neck Cancer |
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| Positive Viral Test in Participants with Lung Cancer |
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| Positive Viral Test in Participants with Prostate Cancer |
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| Positive Viral Test in Participants with Other Cancer |
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Participants with previous HIV diagnosis.
| OG004 | Participants With Any Type Of Viral Infection | Participants diagnosed with any type of viral infection. |
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