Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men
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|ClinicalTrials.gov Identifier: NCT02816879|
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anal Carcinoma HIV Infection Human Papillomavirus Infection||Procedure: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||375 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Screening Tools to Better Predict High-Grade Anal Dysplasia for MSM|
|Study Start Date :||July 9, 2013|
|Estimated Primary Completion Date :||July 31, 2018|
|Estimated Study Completion Date :||July 31, 2019|
Experimental: Screening (anal cytology collection)
Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.
Procedure: Cytology Specimen Collection Procedure
Undergo anal cytology collection
Other Name: Cytologic Sampling
Other: Laboratory Biomarker Analysis
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816879
|United States, California|
|Los Angeles Gay and Lesbian Center||Recruiting|
|Los Angeles, California, United States, 90028|
|Contact: Robert Bolan 323-993-7577 firstname.lastname@example.org|
|Principal Investigator: Robert Bolan|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Dorothy J. Wiley 310-825-0540 email@example.com|
|Principal Investigator: Dorothy J. Wiley|
|Desert AIDS Project||Recruiting|
|Palm Springs, California, United States, 92262|
|Contact: Matt G. Moran firstname.lastname@example.org|
|Principal Investigator: Matt G. Moran|
|Principal Investigator:||Dorothy Wiley||UCLA / Jonsson Comprehensive Cancer Center|