Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Early Invasive Cervical Squamous Cell Carcinoma
- Cervical Adenocarcinoma
- Cervical Adenocarcinoma In Situ
- Cervical Intraepithelial Neoplasia
- Stage III Cervical Cancer AJCC v8
- Stage III Vaginal Cancer AJCC v8
- Stage IVA Vaginal Cancer AJCC v8
- Stage IV Vaginal Cancer AJCC v8
- Vulvar Squamous Intraepithelial Lesion
- Vulvar Intraepithelial Neoplasia
- Stage IA Cervical Cancer AJCC v8
- Stage IV Cervical Cancer AJCC v8
- Stage IVB Vaginal Cancer AJCC v8
- Vaginal Adenocarcinoma
- Stage IVA Vulvar Cancer AJCC v8
- Stage II Vulvar Cancer AJCC v8
- Cervical Squamous Cell Carcinoma, Not Otherwise Specified
- Cervical Squamous Intraepithelial Neoplasia
- Stage II Vaginal Cancer AJCC v8
- Stage IB Vaginal Cancer AJCC v8
- Stage IIA Cervical Cancer AJCC v8
- Stage I Vaginal Cancer AJCC v8
- Early Invasive Cervical Adenocarcinoma
- Stage IA Vaginal Cancer AJCC v8
- Stage IVA Cervical Cancer AJCC v8
- Stage IIB Vaginal Cancer AJCC v8
- Stage IVB Vulvar Cancer AJCC v8
- Stage IA2 Cervical Cancer AJCC v8
- Vulvar Squamous Cell Carcinoma
- Stage IB1 Cervical Cancer AJCC v8
- Stage II Cervical Cancer AJCC v8
- Stage III Vulvar Cancer AJCC v8
- Stage IIIA Vulvar Cancer AJCC v8
- Stage IB Vulvar Cancer AJCC v8
- High Grade Cervical Squamous Intraepithelial Neoplasia
- Vulvar High Grade Squamous Intraepithelial Lesion
- High Grade Vaginal Intraepithelial Neoplasia
- Stage IA Vulvar Cancer AJCC v8
- Stage IIA1 Cervical Cancer AJCC v8
- Low Grade Vaginal Intraepithelial Neoplasia
- Stage I Cervical Cancer AJCC v8
- Stage IIIA Cervical Cancer AJCC v8
- Stage IIB Cervical Cancer AJCC v8
- Stage I Vulvar Cancer AJCC v8
- Vulvar Adenocarcinoma
- Stage IIA2 Cervical Cancer AJCC v8
- Stage IV Vulvar Cancer AJCC v8
- Stage IIIB Vulvar Cancer AJCC v8
- Stage IIIC Vulvar Cancer AJCC v8
- Stage IVB Cervical Cancer AJCC v8
- Stage IIIB Cervical Cancer AJCC v8
- Stage IB Cervical Cancer AJCC v8
- Stage IIA Vaginal Cancer AJCC v8
- Stage IB2 Cervical Cancer AJCC v8
- Stage IA1 Cervical Cancer AJCC v8
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Screening
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 t...
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.
Tracking Information
- NCT #
- NCT02140021
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Kathleen Schmeler M.D. Anderson Cancer Center
Get Well Soon