Screening Strategies Among High-risk Populations for Anal Cancer

RecruitingHealthy volunteers welcome

Who can join

Ages 30 to 80 · All sexes · Healthy volunteers welcome

Full eligibility criteria

Inclusion Criteria:

* 30-80 years of age
* Individuals with chronic impaired immune status
* History of 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.

About the study

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.

What is being tested

HRA + Biopsy (diagnostic test)
Anal Cytology (diagnostic test)
Genotyping of anal hrHPV infection (diagnostic test)
CINtec®PLUS (diagnostic test)

Sponsor: Lisa Flowers · Participants: 500 · Started: Dec 16, 2024

Contact the study team

Lisa Flowers, MD, MPH · Phone: 404-251-8931

Official record on ClinicalTrials.gov — NCT06628570

Locations in the U.S.

Florida	University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami University of Miami School of Medicine at Jackson Memorial Hospital (JMH), Miami
Georgia	Grady Memorial Hospital, Atlanta The Ponce Center, Atlanta

Conditions

Cancer (all types)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.