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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT02140021

Collaborator

National Cancer Institute (NCI) (NIH)

500

Enrollment

Locations

Arm

96.1

Anticipated Duration (Months)

250

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis	N/A

Detailed Description

PRIMARY OBJECTIVES:

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:

To estimate the prevalence of anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.

EXPLORATORY OBJECTIVES:

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.
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.
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.
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.
To estimate the prevalence of oral HPV infection in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Oct 27, 2014

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Screening (biospecimen collection) Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.	Procedure: Biospecimen Collection Undergo anal, cervical, vaginal, and oral sample collection Other: Laboratory Biomarker Analysis Correlative studies

Arm

Intervention/Treatment

Experimental: Screening (biospecimen collection)

Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.

Procedure: Biospecimen Collection

Undergo anal, cervical, vaginal, and oral sample collection

Other: Laboratory Biomarker Analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

Prevalence of invasive squamous cell carcinoma of the anus [Up to 5 years]
Will estimate the prevalence of invasive squamous cell carcinoma of the anus in women with 95% confidence intervals.
Sensitivity and specificity of anal pap testing to diagnose anal dysplasia [Up to 5 years]
Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.
Sensitivity and specificity of anal human papillomavirus (HPV) testing to diagnose anal dysplasia [Up to 5 years]
Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.
Sensitivity and specificity of the combination of anal pap testing + anal HPV testing to diagnose anal dysplasia [Up to 5 years]
Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.