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Active, Not Recruiting

NCT Number: NCT02816879

Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anal Carcinoma Anus Diseases Anus Neoplasms Blood-Borne Infections Colorectal Neoplasms Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases HIV Infection HIV Infections Human Papillomavirus Infection Immune System Diseases Immunologic Deficiency Syndromes Infections Intestinal Diseases Intestinal Neoplasms Lentivirus Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Rectal Diseases Rectal Neoplasms Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Los Angeles Gay and Lesbian Center, Los Angeles, California, United States

Loading trial locations.

About this study

PRIMARY OBJECTIVES:

I. 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Cytology Specimen Collection Procedure

Procedure

Undergo anal cytology collection

Other names: Cytologic Sampling

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. 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.

Secondary outcomes

  1. Ability of APTIMA-HPV to predict risk for HG-AIN

    Time frame: Baseline

    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.

  2. Ability of Hybrid-capture 2 to predict risk for HG-AIN

    Time frame: Baseline

    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.

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Improving Screening Tools to Better Predict High-Grade Anal Dysplasia for MSM

Important dates

Study start
2013
Primary completion
2027
Study completion
2028
First posted
Jun 29, 2016
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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