Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
NCT ID: NCT02140021
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
409 participants
INTERVENTIONAL
2014-10-27
2025-07-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Screening (biospecimen collection)
Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.
Biospecimen Collection
Undergo anal, cervical, vaginal, and oral sample collection
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Biospecimen Collection
Undergo anal, cervical, vaginal, and oral sample collection
Laboratory Biomarker Analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kathleen Schmeler
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Lyndon Baines Johnson General Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2018-02553
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-0021
Identifier Type: OTHER
Identifier Source: secondary_id
2014-0021
Identifier Type: -
Identifier Source: org_study_id
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