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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 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 |

Arm | Intervention/treatment |
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Experimental: Screening (biospecimen collection)
Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.
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Procedure: Biospecimen Collection
Undergo anal, cervical, vaginal, and oral sample collection Other: Laboratory Biomarker Analysis Correlative studies |
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Principal Investigator: | Kathleen Schmeler | M.D. Anderson Cancer Center |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |