Anal CarcinomaNCT02816879
Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men
A study testing Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis in people with Anal Carcinoma and HIV Infection, run by Jonsson Comprehensive Cancer Center at 3 sites in United States.
Trial summary
This clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anal Carcinoma, HIV Infection, Human Papillomavirus Infection
- What is being tested?
- Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2013to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males who self-identify as having had or currently having sex with men; both human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects are being enrolled
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Los Angeles Gay and Lesbian Center
Los Angeles, California, 90028
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Desert AIDS Project
Palm Springs, California, 92262
About this study
Official title: Improving Screening Tools to Better Predict High-Grade Anal Dysplasia for MSM
This clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. This study may help doctors develop better screening for high-grade anal dysplasia in MSM in order to identify those who need to return for additional screening and treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the sensitivity \& specificity, predictive positive value (PPV), \& predictive negative value (PNV) (test characteristics) \& cellularity, beta-globin, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), \& protein (quality measures) from nylon-flocked (NF)- \& Dacron-swab protocols to detect biopsy-detected high-grade anal intraepithelial neoplasia (HG-AIN) \& human papillomavirus (HPV)-infections, using randomized-controlled study design.
II. Evaluate the test characteristics for anal cancer screening algorithms that incorporate sequentially or simultaneously performed high-threshold molecular HPV tests, with \& without cytology, to predict HG-AIN.
III. Evaluate the cost-effectiveness \& relative cost of single- \& multiple-test anal cancer screening algorithms.
OUTLINE:
Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Papanicolaou (Pap) staining, HPV genotyping, and polymerase chain reaction (PCR).
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis
- 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.
Cytology Specimen Collection ProcedureProcedure or surgery
Also called Cytologic Sampling
Undergo anal cytology collection
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Screening (anal cytology collection) | Experimental | Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR. Receives: Procedure: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome
Two contingency tables will contrast cytology classification (for each swab type) with anal intraepithelial neoplasia (AIN) diagnosis based upon high-resolution anoscopy (HRA) \& histology.
Measured: Baseline
Secondary outcomes (3)
Ability of APTIMA-HPV to predict risk for HG-AIN
Two contingency tables will contrast HPV infection characteristics for APTIMA-HPV \& HC-2 compared to PCR based genotyping using Linear Array assay. Kappa statistics will be estimated to evaluate the observed versus expected agreement between the Linear Array assay (gold standard) \& the findings for APTIMA-HPV \& HC-2, separately. Prevalence estimates for 37 individual HPVs will be estimated from the data; also, for each type, agreement between the NF- \& Dacron protocols for HPV genotypes will be summarized in tabular \& graphical form.
Measured: Baseline
Ability of Hybrid-capture 2 to predict risk for HG-AIN
Two contingency tables will contrast HPV infection characteristics for APTIMA-HPV \& HC-2 compared to PCR based genotyping using Linear Array assay. Kappa statistics will be estimated to evaluate the observed versus expected agreement between the Linear Array assay (gold standard) \& the findings for APTIMA-HPV \& HC-2, separately. Prevalence estimates for 37 individual HPVs will be estimated from the data; also, for each type, agreement between the NF- \& Dacron protocols for HPV genotypes will be summarized in tabular \& graphical form.
Measured: Baseline
Cost effectiveness analysis evaluating differences in survival, the cost of out-patient procedures & in-patient hospitalizations for invasive anal cancer.
The cost-effectiveness analyses calculate incremental cost-effectiveness ratios (ICERs) comparing two intervention groups/strategies to the current standard of care, Dacron cytology alone. The ICER is the ratio of the difference in the total costs per patient between groups (numerator) versus the difference in quality-adjusted life-years (QALY) between groups (denominator). Specifically, for these analyses, ICERs are separately estimated for best single \& best combination screening algorithm relative to usual care (Dacron-cytology). The analysis focuses on life-time costs.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start1 Aug 2013
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Dorothy Wiley, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816879
- Sponsor's protocol ID
- 13-000997
- Other IDs
- NCI-2014-01292, JCCCID370, RCA169508A, R01CA169508
- Status last verified
- Jul 2026
- First submitted
- 23 May 2016
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Screening Tools to Better Predict High-Grade Anal Dysplasia for MSM
- ClinicalTrials.gov ID
- NCT02816879
- Acronym / sponsor ID
- 13-000997
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
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 compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. This study may help doctors develop better screening for high-grade anal dysplasia in MSM in order to identify those who need to return for additional screening and treatment.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate the sensitivity \& specificity, predictive positive value (PPV), \& predictive negative value (PNV) (test characteristics) \& cellularity, beta-globin, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), \& protein (quality measures) from nylon-flocked (NF)- \& Dacron-swab protocols to detect biopsy-detected high-grade anal intraepithelial neoplasia (HG-AIN) \& human papillomavirus (HPV)-infections, using randomized-controlled study design.
II. Evaluate the test characteristics for anal cancer screening algorithms that incorporate sequentially or simultaneously performed high-threshold molecular HPV tests, with \& without cytology, to predict HG-AIN.
III. Evaluate the cost-effectiveness \& relative cost of single- \& multiple-test anal cancer screening algorithms.
OUTLINE:
Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Papanicolaou (Pap) staining, HPV genotyping, and polymerase chain reaction (PCR).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (anal cytology collection) | Experimental | Procedure: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker AnalysisPatients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males who self-identify as having had or currently having sex with men; both human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects are being enrolled
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo anal cytology collection | Procedure or surgery | Screening (anal cytology collection) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Screening (anal cytology collection) |
Primary outcome
Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome
Time frame: Baseline
Two contingency tables will contrast cytology classification (for each swab type) with anal intraepithelial neoplasia (AIN) diagnosis based upon high-resolution anoscopy (HRA) \& histology.
3 secondary outcomes
Ability of APTIMA-HPV to predict risk for HG-AIN
Time frame: Baseline
Ability of Hybrid-capture 2 to predict risk for HG-AIN
Time frame: Baseline
Cost effectiveness analysis evaluating differences in survival, the cost of out-patient procedures & in-patient hospitalizations for invasive anal cancer.
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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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.
Dorothy Wiley principal investigator
UCLA / Jonsson Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis in people with Anal Carcinoma and HIV Infection, run by Jonsson Comprehensive Cancer Center at 3 sites in United States.
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 1 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome (time frame: Baseline). 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 Jul 2026.