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

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.

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.