Clinical Trials Directory

Trials / Terminated

TerminatedNCT02140021

Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer

Prevalence of Anal Dysplasia and Anal Cancer in Women With Cervical, Vaginal and Vulvar Dysplasia and Cancer

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
409 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This trial studies the prevalence of anal dysplasia and anal cancer in patients with cervical, vaginal, and vulvar dysplasia and cancer. Studying samples collected from patients in the laboratory may help doctors learn more about the human papillomavirus and how often anal cancer occurs in patients with cervix, vagina, or vulvar cancer.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the prevalence of invasive squamous cell carcinoma of the anus in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva. SECONDARY OBJECTIVES: I. To estimate the prevalence of anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva. EXPLORATORY OBJECTIVES: I. To estimate the clinical performance (sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios) of anal pap testing to diagnose anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva. II. To estimate the clinical performance (sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios) of anal high-risk human papillomavirus (HPV) testing to diagnose anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva. III. To estimate the clinical performance (sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios) of anal pap testing and HPV testing (anal "cotesting") to diagnose anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva. IV. To determine associations between gut and cervical microbiomes and anal dysplasia/carcinoma in women with high-grade dysplasia or carcinoma of the cervix, vagina, or vulva. V. To estimate the prevalence of oral HPV infection in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva. VI. To compare a new HPV point of care test developed by Rice University with current standard HPV testing. OUTLINE: Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiospecimen CollectionUndergo anal, cervical, vaginal, and oral sample collection
OTHERLaboratory Biomarker AnalysisCorrelative studies

Timeline

Start date
2014-10-27
Primary completion
2025-07-08
Completion
2025-07-08
First posted
2014-05-16
Last updated
2025-07-14

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02140021. Inclusion in this directory is not an endorsement.