Anal CancerNCT01946139
Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV
A study testing comparison of screening methods, laboratory biomarker analysis and questionnaire administration in people with Anal Cancer and HIV Infection, run by AIDS Malignancy Consortium at 12 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anal Cancer, HIV Infection, Human Papilloma Virus Infection
- What is being tested?
- comparison of screening methods, laboratory biomarker analysis and questionnaire administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 4 Dec 2013to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive; HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
- Karnofsky performance status > 70%
- Absolute neutrophil count >= 750 cells/mm^3 within 120 days of study entry
- Platelet count >= 75,000 cells/mm^3 within 120 days of study entry
Who cannot join
- Current or history of anal or perianal carcinoma
- History of anal HSIL cytology or histology
- Known permanent or irreversible bleeding disorder, or any illness that, in the opinion of the clinical investigator, would contraindicate any biopsy of the anal canal
- For women able to conceive, evidence of pregnancy by a positive urinary pregnancy test; pregnant women are excluded from enrollment in this study
- Serious medical or psychiatric illness that in the opinion of the site Investigator will interfere with the ability of the subject to give informed consent or adhere to the protocol
- Ongoing use of anticoagulant therapy other than aspirin, clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDS)
- Inability to provide informed consent
- Treatment of anal and/or perianal HPV associated disease (i.e., condyloma or low-grade anal intraepithelial neoplasia [AIN]) within 4 months of study entry
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Boston University Cancer Research Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
John H. Stroger Hospital of Cook County
Chicago, Illinois, 60612
Baylor College of Medicine
Houston, Texas, 77030
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, 90095-1793
Weill-Cornell Medical College
New York, New York, 10010
Laser Surgery Care Center
New York, New York, 10011
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15261
Ucsf Ancre
San Francisco, California, 94115
Montefiore Medical Center
The Bronx, New York, 10461
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Puerto Rico1 site
University of Puerto Rico Comprehensive Cancer Center
San Juan, 00929-0134
About this study
Official title: Screening HIV-Infected Women for Anal Cancer Precursors
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Anal Cancer, HIV Infection, Human Papilloma Virus Infection
- Being tested
- comparison of screening methods, laboratory biomarker analysis, questionnaire administration, quality-of-life assessment
- Medical subject headings
- Anus Neoplasms, HIV Infections, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of screening methodsProcedure or surgery
Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysisOther
Correlative studies
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: comparison of screening methods; Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Secondary outcomes (1)
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
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study start4 Dec 2013
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Chiao, Principal investigator, AIDS Associated Malignancies Clinical Trials Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946139
- Sponsor's protocol ID
- AMC-084
- Other IDs
- NCI-2013-01637, AMC-084, AMC-084, R01CA163103, U01CA121947
- Status last verified
- Apr 2023
- First submitted
- 17 Sep 2013
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening HIV-Infected Women for Anal Cancer Precursors
- ClinicalTrials.gov ID
- NCT01946139
- Acronym / sponsor ID
- AMC-084
- Conditions
- Anal Cancer, HIV Infection, Human Papilloma Virus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Dec 2013 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Posted 30 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (HSIL detection) | Experimental | Procedure: comparison of screening methods, Other: laboratory biomarker analysis, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV positive; HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
- Karnofsky performance status > 70%
- Absolute neutrophil count >= 750 cells/mm^3 within 120 days of study entry
- Platelet count >= 75,000 cells/mm^3 within 120 days of study entry
Key exclusion criteria (8 listed)
- Current or history of anal or perianal carcinoma
- History of anal HSIL cytology or histology
- Known permanent or irreversible bleeding disorder, or any illness that, in the opinion of the clinical investigator, would contraindicate any biopsy of the anal canal
- For women able to conceive, evidence of pregnancy by a positive urinary pregnancy test; pregnant women are excluded from enrollment in this study
- Serious medical or psychiatric illness that in the opinion of the site Investigator will interfere with the ability of the subject to give informed consent or adhere to the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparison of screening methodsUndergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays | Procedure or surgery | Screening (HSIL detection) |
| laboratory biomarker analysisCorrelative studies | Other | Screening (HSIL detection) |
| questionnaire administrationAncillary studies | Other | Screening (HSIL detection) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Screening (HSIL detection) |
Primary outcome
Specificity of Each Other Methods of HSIL Detection for APTIMA Assay
Time frame: at baseline
Among patients who are HRA negative for HSIL, the number of participants who tested negative for HSIL on the APTIMA assay
Prevalence of HSIL
Time frame: at baseline
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.
Sensitivity of Each of the Methods of APTIMA Assay at Baseline
Time frame: 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.
Incidence of HSIL Among Women Who Were HRA Negative for HSIL at Study Entry
Time frame: Up to 2 years
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.
1 secondary outcome
Acceptability of Anal Cancer Screening
Time frame: at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Chiao principal investigator
AIDS Associated Malignancies Clinical Trials Consortium
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparison of screening methods, laboratory biomarker analysis and questionnaire administration in people with Anal Cancer and HIV Infection, run by AIDS Malignancy Consortium at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of Each Other Methods of HSIL Detection for APTIMA Assay (time frame: at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.