NCT02140021

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
409

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

October 27, 2014

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

10.7 years

First QC Date

May 14, 2014

Last Update Submit

July 9, 2025

Conditions

Cervical AdenocarcinomaCervical Adenocarcinoma In SituCervical Intraepithelial NeoplasiaCervical Squamous Cell Carcinoma, Not Otherwise SpecifiedCervical Squamous Intraepithelial NeoplasiaEarly Invasive Cervical AdenocarcinomaEarly Invasive Cervical Squamous Cell CarcinomaHigh Grade Cervical Squamous Intraepithelial NeoplasiaHigh Grade Vaginal Intraepithelial NeoplasiaLow Grade Vaginal Intraepithelial NeoplasiaStage I Cervical Cancer AJCC v8Stage I Vaginal Cancer AJCC v8Stage I Vulvar Cancer AJCC v8Stage IA Cervical Cancer AJCC v8Stage IA Vaginal Cancer AJCC v8Stage IA Vulvar Cancer AJCC v8Stage IA1 Cervical Cancer AJCC v8Stage IA2 Cervical Cancer AJCC v8Stage IB Cervical Cancer AJCC v8Stage IB Vaginal Cancer AJCC v8Stage IB Vulvar Cancer AJCC v8Stage IB1 Cervical Cancer AJCC v8Stage IB2 Cervical Cancer AJCC v8Stage II Cervical Cancer AJCC v8Stage II Vaginal Cancer AJCC v8Stage II Vulvar Cancer AJCC v8Stage IIA Cervical Cancer AJCC v8Stage IIA Vaginal Cancer AJCC v8Stage IIA1 Cervical Cancer AJCC v8Stage IIA2 Cervical Cancer AJCC v8Stage IIB Cervical Cancer AJCC v8Stage IIB Vaginal Cancer AJCC v8Stage III Cervical Cancer AJCC v8Stage III Vaginal Cancer AJCC v8Stage III Vulvar Cancer AJCC v8Stage IIIA Cervical Cancer AJCC v8Stage IIIA Vulvar Cancer AJCC v8Stage IIIB Cervical Cancer AJCC v8Stage IIIB Vulvar Cancer AJCC v8Stage IIIC Vulvar Cancer AJCC v8Stage IV Cervical Cancer AJCC v8Stage IV Vaginal Cancer AJCC v8Stage IV Vulvar Cancer AJCC v8Stage IVA Cervical Cancer AJCC v8Stage IVA Vaginal Cancer AJCC v8Stage IVA Vulvar Cancer AJCC v8Stage IVB Cervical Cancer AJCC v8Stage IVB Vaginal Cancer AJCC v8Stage IVB Vulvar Cancer AJCC v8Vaginal AdenocarcinomaVulvar AdenocarcinomaVulvar High Grade Squamous Intraepithelial LesionVulvar Intraepithelial NeoplasiaVulvar Squamous Cell CarcinomaVulvar Squamous Intraepithelial Lesion

Outcome Measures

Primary Outcomes (4)

  • Prevalence of invasive squamous cell carcinoma of the anus

    Will estimate the prevalence of invasive squamous cell carcinoma of the anus in women with 95% confidence intervals.

    Up to 5 years

  • Sensitivity and specificity of anal pap testing to diagnose anal dysplasia

    Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.

    Up to 5 years

  • Sensitivity and specificity of anal human papillomavirus (HPV) testing to diagnose anal dysplasia

    Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.

    Up to 5 years

  • Sensitivity and specificity of the combination of anal pap testing + anal HPV testing to diagnose anal dysplasia

    Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.

    Up to 5 years

Study Arms (1)

Screening (biospecimen collection)

EXPERIMENTAL

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

Procedure: Biospecimen CollectionOther: Laboratory Biomarker Analysis

Interventions

Biospecimen CollectionPROCEDURE

Undergo anal, cervical, vaginal, and oral sample collection

Screening (biospecimen collection)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Screening (biospecimen collection)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lyndon Baines Johnson General Hospital

Houston, Texas, 77026-1967, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical NeoplasmsVaginal NeoplasmsVulvar Neoplasms

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteVaginal DiseasesVulvar Diseases

Study Officials

  • Kathleen Schmeler

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 16, 2014

Study Start

October 27, 2014

Primary Completion

July 8, 2025

Study Completion

July 8, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations

US(2)