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

Not Applicable

Active, not recruiting

• Conditions: 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
• Interventions: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis

• Registration Number: NCT02140021
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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.

Study Timeline

• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-16
• Study Start: 2014-10-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 409

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening (biospecimen collection)	Biospecimen Collection	Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.
Screening (biospecimen collection)	Laboratory Biomarker Analysis	Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.

Primary Outcome Measures

Name	Time	Method
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.
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 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.

Trial Locations

Locations (2)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Lyndon Baines Johnson General Hospital; 🇺🇸 Houston, Texas, United States