Clinical trial NCT02140021: Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
Official title: Prevalence of Anal Dysplasia and Anal Cancer in Women With Cervical, Vaginal and Vulvar Dysplasia and Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-16
Enrollment: 409
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Eligibility 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.

Primary outcomes:
measure: Prevalence of invasive squamous cell carcinoma of the anus
timeFrame: Up to 5 years
measure: Sensitivity and specificity of anal pap testing to diagnose anal dysplasia
timeFrame: Up to 5 years
measure: Sensitivity and specificity of anal human papillomavirus (HPV) testing to diagnose anal dysplasia
timeFrame: Up to 5 years
measure: Sensitivity and specificity of the combination of anal pap testing + anal HPV testing to diagnose anal dysplasia
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon Baines Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathleen Schmeler
role: PRINCIPAL_INVESTIGATOR
References: