Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
375

Summary

Conditions
  • Anal Carcinoma
  • HIV Infection
  • Human Papillomavirus Infection
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Screening

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

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-swa...

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).

Tracking Information

NCT #
NCT02816879
Collaborators
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
Investigators
Principal Investigator: Dorothy Wiley UCLA / Jonsson Comprehensive Cancer Center
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