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NCT06628570NARecruitingAccepts Healthy Volunteers

Screening Strategies Among High-risk Populations for Anal Cancer

Lisa Flowers

Start Date

12/16/2024

Completion Date

10/1/2027

Summary

The goal of the proposed research is to 1) examine the performance of emerging screening methods for anal high-grade squamous intraepithelial lesion (aHSIL), a precancerous condition of anal cancer, among populations at high risk for anal cancer and 2) characterize DNA methylation, immunologic response, and environmental factors associated with aHSIL.

Detailed Description

Anal cancer, caused by persistent infection with high-risk human papillomavirus (hrHPV), is typically preceded by anal high-grade squamous intraepithelial lesions (aHSIL). The incidence and mortality of advanced anal cancer has been increasing in the U.S., with the greatest burden of disease and mortality in individuals with chronic impairment of the immune system. The study is important because the incidence of anal cancer is particularly high among certain groups. Findings will provide much-needed evidence for anal cancer screening strategies to reduce incidence of anal cancer and improve health outcomes. The study population includes individuals with chronic impairment of the immune system and females with a known history of high-grade lower genital tract neoplasia. The study procedures include filling out self-reported questionnaires and collecting biosamples for study-related assays. HRA is part of the standard clinic procedure for this group of participants. Collected biosamples will be banked for future research use. In-person or remote signed consent may occur for the study.

Eligibility Criteria

Age Range: 30 years to 80 years

Inclusion Criteria: * 30-80 years of age * Individuals with chronic impaired immune status * History of high-grade lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2; Exclusion Criteria: * Patients treated for aHSIL less than 6 months before screening, * History of anal cancer and pregnant women.

Interventions

DIAGNOSTIC_TEST

HRA + Biopsy

DIAGNOSTIC_TEST

Anal Cytology

DIAGNOSTIC_TEST

Genotyping of anal hrHPV infection

DIAGNOSTIC_TEST

CINtec®PLUS

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Conditions

NeoplasmsHPV-Related Anal Squamous Cell Carcinoma

Locations

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida 33136

United States

University of Miami School of Medicine at Jackson Memorial Hospital (JMH)

Miami, Florida 33136

United States

Grady Memorial Hospital

Atlanta, Georgia 30303

United States

The Ponce Center

Atlanta, Georgia 30308

United States