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

NCT02140021 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 409

Last updated 2025-07-14

No results posted yet for this study

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.

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
  • 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

Interventions

PROCEDURE

Biospecimen Collection

Undergo anal, cervical, vaginal, and oral sample collection

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Kathleen Schmeler · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-27
Primary Completion
2025-07-08
Completion
2025-07-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02140021 on ClinicalTrials.gov