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

  • STATUS
    Recruiting
  • participants needed
    500
  • sponsor
    M.D. Anderson Cancer Center
Updated on 29 November 2022
cancer
carcinoma
squamous cell carcinoma
dysplasia
adenocarcinoma
human papillomavirus
hsil

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.

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.

Details
Condition Cervical Adenocarcinoma, Cervical Adenocarcinoma In Situ, Cervical Intraepithelial Neoplasia, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Cervical Squamous Intraepithelial Neoplasia, Early Invasive Cervical Adenocarcinoma, Early Invasive Cervical Squamous Cell Carcinoma, High Grade Cervical Squamous Intraepithelial Neoplasia, High Grade Vaginal Intraepithelial Neoplasia, Low Grade Vaginal Intraepithelial Neoplasia, Stage I Cervical Cancer AJCC v8, Stage I Vaginal Cancer AJCC v8, Stage I Vulvar Cancer AJCC v8, Stage IA Cervical Cancer AJCC v8, Stage IA Vaginal Cancer AJCC v8, Stage IA Vulvar Cancer AJCC v8, Stage IA1 Cervical Cancer AJCC v8, Stage IA2 Cervical Cancer AJCC v8, Stage IB Cervical Cancer AJCC v8, Stage IB Vaginal Cancer AJCC v8, Stage IB Vulvar Cancer AJCC v8, Stage IB1 Cervical Cancer AJCC v8, Stage IB2 Cervical Cancer AJCC v8, Stage II Cervical Cancer AJCC v8, Stage II Vaginal Cancer AJCC v8, Stage II Vulvar Cancer AJCC v8, Stage IIA Cervical Cancer AJCC v8, Stage IIA Vaginal Cancer AJCC v8, Stage IIA1 Cervical Cancer AJCC v8, Stage IIA2 Cervical Cancer AJCC v8, Stage IIB Cervical Cancer AJCC v8, Stage IIB Vaginal Cancer AJCC v8, Stage III Cervical Cancer AJCC v8, Stage III Vaginal Cancer AJCC v8, Stage III Vulvar Cancer AJCC v8, Stage IIIA Cervical Cancer AJCC v8, Stage IIIA Vulvar Cancer AJCC v8, Stage IIIB Cervical Cancer AJCC v8, Stage IIIB Vulvar Cancer AJCC v8, Stage IIIC Vulvar Cancer AJCC v8, Stage IV Cervical Cancer AJCC v8, Stage IV Vaginal Cancer AJCC v8, Stage IV Vulvar Cancer AJCC v8, Stage IVA Cervical Cancer AJCC v8, Stage IVA Vaginal Cancer AJCC v8, Stage IVA Vulvar Cancer AJCC v8, Stage IVB Cervical Cancer AJCC v8, Stage IVB Vaginal Cancer AJCC v8, Stage IVB Vulvar Cancer AJCC v8, Vaginal Adenocarcinoma, Vulvar Adenocarcinoma, Vulvar High Grade Squamous Intraepithelial Lesion, Vulvar Intraepithelial Neoplasia, Vulvar Squamous Cell Carcinoma, Vulvar Squamous Intraepithelial Lesion
Treatment laboratory biomarker analysis, biospecimen collection, Anoscopy, Anal Pap Test
Clinical Study IdentifierNCT02140021
SponsorM.D. Anderson Cancer Center
Last Modified on29 November 2022

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