Title
Anal Dysplasia Registry

Description
Anal Dysplasia Registry

Objective
Primary Endpoints:
1. To determine the risks factors for anal dysplasia that would allow for identification of which patients should undergo screening.
2. To determine the feasibility of utilizing biomarkers (digital PCR and tissue biomarkers) to predict the risk of disease progression or regression.
3. To evaluate novel biomarkers as predictive for anal cancer development.

Secondary Endpoints:
1. To assess the dysplasia downstaging, pathologic complete response rate, and two-year disease-free survival of patients undergoing standard of care treatments for anal dysplasia.

Treatment The anogenital dysplasia registry is a research investigation, NOT a research intervention. All standard-of-care functions will be performed per standard procedures. The research component of this study is to obtain tissue, blood, and local tissue swabs from appropriate subjects enrolled, observe the outcomes of enrolled patients within the registry and correlate those outcomes with identified biomarkers. A team member will consent patients, track participant progress through the study, and collect and record data elements. Patients will be consented so the study can obtain their clinical data, blood,remnant anal tissue, and local tissue swab, if appropriate, which is to be obtained during standard-of-care procedures.

Key Eligibility Inclusion Criteria for all cohorts:
1. Patients must be >/= 18 years of age.
2. Patients must have a histologically or cytologically suspected or confirmed diagnosis of anogenital dysplasia.
3. Or have one of the known risk factors for anogenital dysplasia (HIV positive, immunosuppressed or genital warts undergoing routine surveillance for anogenital dysplasia).
4. Written informed consent.

There are no exclusion criteria.
Inclusion of Women and Minorities: Both men and women and members of all races and ethnic groups are eligible.

Applicable Disease Sites
Anal; Colon and Rectum

Participating Institutions
UW Health University Hospital