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

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ClinicalTrials.gov Identifier: NCT02140021
Recruitment Status : Recruiting
First Posted : May 16, 2014
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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 : October 27, 2014
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Prevalence of invasive squamous cell carcinoma of the anus [ Time Frame: Up to 5 years ]
    Will estimate the prevalence of invasive squamous cell carcinoma of the anus in women with 95% confidence intervals.

  2. Sensitivity and specificity of anal pap testing to diagnose anal dysplasia [ Time Frame: Up to 5 years ]
    Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.

  3. Sensitivity and specificity of anal human papillomavirus (HPV) testing to diagnose anal dysplasia [ Time Frame: Up to 5 years ]
    Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.

  4. Sensitivity and specificity of the combination of anal pap testing + anal HPV testing to diagnose anal dysplasia [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140021


Locations
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United States, Texas
Lyndon Baines Johnson General Hospital Recruiting
Houston, Texas, United States, 77026-1967
Contact: Kathleen M. Schmeler    713-566-9090      
Principal Investigator: Kathleen M. Schmeler         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Kathleen M. Schmeler    713-745-3518      
Principal Investigator: Kathleen M. Schmeler         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kathleen Schmeler M.D. Anderson Cancer Center
More Information
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02140021     History of Changes
Other Study ID Numbers: 2014-0021
NCI-2018-02553 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0021 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Uterine Cervical Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Anus Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Squamous Intraepithelial Lesions of the Cervix
Adenocarcinoma in Situ
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
 Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases