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

M.D. Anderson Cancer Center

Status

Terminated

Conditions

Stage IIB Vaginal Cancer AJCC v8

Stage IB Vulvar Cancer AJCC v8

Stage IA Cervical Cancer AJCC v8

Stage II Vaginal Cancer AJCC v8

Vulvar High Grade Squamous Intraepithelial Lesion

Stage I Vaginal Cancer AJCC v8

Low Grade Vaginal Intraepithelial Neoplasia

Stage IIA1 Cervical Cancer AJCC v8

Stage IB1 Cervical Cancer AJCC v8

Stage IV Vaginal Cancer AJCC v8

Stage III Vaginal Cancer AJCC v8

Vulvar Adenocarcinoma

Stage IA1 Cervical Cancer AJCC v8

Stage IIIA Cervical Cancer AJCC v8

Cervical Adenocarcinoma

High Grade Vaginal Intraepithelial Neoplasia

Stage IIIC Vulvar Cancer AJCC v8

Stage IIIB Vulvar Cancer AJCC v8

Vaginal Adenocarcinoma

Stage IIA2 Cervical Cancer AJCC v8

Stage IB Vaginal Cancer AJCC v8

Stage IV Vulvar Cancer AJCC v8

Vulvar Intraepithelial Neoplasia

Vulvar Squamous Intraepithelial Lesion

Stage II Vulvar Cancer AJCC v8

Stage IB2 Cervical Cancer AJCC v8

Stage IVB Cervical Cancer AJCC v8

Stage IV Cervical Cancer AJCC v8

Stage IIB Cervical Cancer AJCC v8

Stage IIA Vaginal Cancer AJCC v8

Stage IA2 Cervical Cancer AJCC v8

Stage IA Vulvar Cancer AJCC v8

Cervical Adenocarcinoma In Situ

Stage IVA Vulvar Cancer AJCC v8

Cervical Intraepithelial Neoplasia

Vulvar Squamous Cell Carcinoma

Stage IA Vaginal Cancer AJCC v8

Stage I Cervical Cancer AJCC v8

Cervical Squamous Intraepithelial Neoplasia

Stage IIA Cervical Cancer AJCC v8

Stage IIIB Cervical Cancer AJCC v8

Stage II Cervical Cancer AJCC v8

Stage IVB Vulvar Cancer AJCC v8

Stage IB Cervical Cancer AJCC v8

Stage I Vulvar Cancer AJCC v8

Early Invasive Cervical Squamous Cell Carcinoma

Stage IIIA Vulvar Cancer AJCC v8

Stage IVB Vaginal Cancer AJCC v8

Stage III Cervical Cancer AJCC v8

Stage III Vulvar Cancer AJCC v8

Stage IVA Vaginal Cancer AJCC v8

Cervical Squamous Cell Carcinoma, Not Otherwise Specified

High Grade Cervical Squamous Intraepithelial Neoplasia

Stage IVA Cervical Cancer AJCC v8

Early Invasive Cervical Adenocarcinoma

Treatments

Other: Laboratory Biomarker Analysis

Procedure: Biospecimen Collection

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02140021

2014-0021 (Other Identifier)

NCI-2018-02553 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

409 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women with histologically confirmed cervical, vaginal or vulvar high-grade dysplasia, invasive squamous cell carcinoma, invasive adenocarcinoma, or adenocarcinoma-in-situ (AIS). All stages and grades will be eligible.
Women with a diagnosis of high grade intraepithelial lesion (HSIL) from a routine pap test.
Patients must sign an approved informed consent document.

Exclusion criteria

Patients with previously documented perianal squamous cell dysplasia or invasive squamous cell carcinoma of the anus or anal canal.
Patients unwilling or unable to provide informed consent for the study.
Male patients will not be included in this study.
Patients with previously documented HPV related oropharyngeal cancer.