Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01637 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| AMC-084 | Other Identifier | AIDS - Associated Malignancies Clinical Trials Consortium | |
| AMC-084 | Other Identifier | CTEP | |
| R01CA163103 | U.S. NIH Grant/Contract | View source | |
| U01CA121947 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may help doctors find cancer cells early and plan better treatment for anal cancer. Completing multiple screening tests may help find the best method for detecting cell changes in the anus.
PRIMARY OBJECTIVES:
I. To determine the sensitivity and specificity of HPV testing using different methods of detection, including HPV Hybrid Capture 2 (HC2), HPV messenger ribonucleic acid (mRNA) assays (APTIMA) and OncoHealth HPV E6/E7 oncoprotein assay and whether they improve the screening performance of routine anal cytology for the detection of anal high-grade squamous intraepithelial lesions (HSIL) when measured against the gold standard, biopsy-proven HSIL.
II. To determine the prevalence and risk factors for prevalent HSIL in HIV-infected women.
III. To determine incidence and risk factors associated with anal HSIL and HPV over 2 years among HIV infected women undergoing semi-annual anal evaluations.
EXPLORATORY OBJECTIVES:
I. To evaluate the acceptability of anal cancer screening among HIV-infected women.
II. To collect data on quality of life and health care costs (including non-direct health care costs and time costs) for an economic evaluation of the cost-effectiveness of anal cancer screening strategies in HIV-positive women.
OUTLINE:
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 12 and 24 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (HSIL detection) | Experimental | Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comparison of screening methods | Procedure | Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of Each Other Methods of HSIL Detection for APTIMA Assay | Among patients who are HRA negative for HSIL, the number of participants who tested negative for HSIL on the APTIMA assay | at baseline |
| Prevalence of HSIL | The prevalence of HSIL will be estimated as the proportion of women who are HRA positive for HSIL at entry and its 95% confidence interval. Logistic regression analysis will be used to evaluate the association of potential risk factors with diagnosis of HSIL. | at baseline |
| Sensitivity of Each of the Methods of APTIMA Assay at Baseline | Among patients whose high resolution anoscopy (HRA) results were positive for HSIL and had APTIMA assays at baseline, the number whose APTIMA assay results were positive. | at baseline |
| Incidence of HSIL Among Women Who Were HRA Negative for HSIL at Study Entry | The Poisson rate and its 95% confidence interval will be estimated from the number of HSIL cases detected divided by the cumulative years of follow-up across these cases. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Anal Cancer Screening | Anal cancer screening is typically done using a high resolution anoscopy, a device which allows visualization of the anus. To determine if participants found anal screening acceptable, they were asked if they were at east with having a high resolution anoscopy. The results indicated the number of participants who felt at ease with having a high resolution anoscopy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Chiao | AIDS Associated Malignancies Clinical Trials Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Clinical AIDS Research and Education (CARE) Center | Los Angeles | California | 90095-1793 | United States | ||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Screening (HSIL Detection) | Patients undergo screening for the detection of high grade squamous intraepithelial lesions (HSIL) using anal cytology, human papillomavirus (HPV) hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months. comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays laboratory biomarker analysis: Correlative studies questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| laboratory biomarker analysis | Other | Correlative studies |
|
| questionnaire administration | Other | Ancillary studies |
|
| quality-of-life assessment | Procedure | Ancillary studies |
|
|
| at baseline |
| Ucsf Ancre |
| San Francisco |
| California |
| 94115 |
| United States |
| John H. Stroger Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Weill-Cornell Medical College | New York | New York | 10010 | United States |
| Laser Surgery Care Center | New York | New York | 10011 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | 15261 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Puerto Rico Comprehensive Cancer Center | San Juan | 00929-0134 | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants who were entered into the AMC084 study
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Screening (HSIL Detection) | Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months. comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays laboratory biomarker analysis: Correlative studies questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Anal HSIL at baseline | 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 | Specificity of Each Other Methods of HSIL Detection for APTIMA Assay | Among patients who are HRA negative for HSIL, the number of participants who tested negative for HSIL on the APTIMA assay | Participants who were negative for HSIL on the high resolution anoscopy at baseline and who had APTIMA assay results | Posted | Count of Participants | Participants | at baseline |
|
|
| ||||||||||||||||||||||||||
| Primary | Prevalence of HSIL | The prevalence of HSIL will be estimated as the proportion of women who are HRA positive for HSIL at entry and its 95% confidence interval. Logistic regression analysis will be used to evaluate the association of potential risk factors with diagnosis of HSIL. | Posted | Count of Participants | Participants | at baseline |
|
| ||||||||||||||||||||||||||||
| Primary | Sensitivity of Each of the Methods of APTIMA Assay at Baseline | Among patients whose high resolution anoscopy (HRA) results were positive for HSIL and had APTIMA assays at baseline, the number whose APTIMA assay results were positive. | Patients whose HRA results were positive and had APTIMA results at baseline | Posted | Count of Participants | Participants | at baseline |
|
| |||||||||||||||||||||||||||
| Primary | Incidence of HSIL Among Women Who Were HRA Negative for HSIL at Study Entry | The Poisson rate and its 95% confidence interval will be estimated from the number of HSIL cases detected divided by the cumulative years of follow-up across these cases. | Participants who did not have HSIL at baseline based on the high resolution anoscopy (HRA) results and who had follow-up HRA results | Posted | Number | 95% Confidence Interval | events per 100 person-years | Up to 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Acceptability of Anal Cancer Screening | Anal cancer screening is typically done using a high resolution anoscopy, a device which allows visualization of the anus. To determine if participants found anal screening acceptable, they were asked if they were at east with having a high resolution anoscopy. The results indicated the number of participants who felt at ease with having a high resolution anoscopy | Posted | Count of Participants | Participants | at baseline |
|
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Screening (HSIL Detection) | Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months. comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays laboratory biomarker analysis: Correlative studies questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | 1 | 256 | 4 | 256 | 17 | 256 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain - Cardiac | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Bone infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorder, other | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blurred vision | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Eye disorders, other | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anal hemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Injury, poisoning and procedural complications, other | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pregnancy, puerperium and perinatal conditions, other | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Surgical and medical procedures, other | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Mosby-Griffin | Emmes Company, LLC | 301 251-1161 | 10158 | kmosby@emmes.com |
| Jun 28, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 17, 2014 | Jun 28, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| D015658 | HIV Infections |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004266 | DNA Virus Infections |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|