Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/14/2017 |
| Start Date: | July 9, 2013 |
| End Date: | July 31, 2019 |
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.
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.
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).
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).
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
We found this trial at
3
sites
Los Angeles, California 90095
Principal Investigator: Dorothy J. Wiley
Phone: 310-825-0540
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Los Angeles, California 90028
Principal Investigator: Robert Bolan
Phone: 323-993-7577
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