Screening Strategies Among High-risk Populations for Anal Cancer

Last updated: September 2, 2025
Sponsor: Lisa Flowers
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Anal Dysplasia

Treatment

Anal Cytology

Genotyping of anal hrHPV infection

CINtec®PLUS

Clinical Study ID

NCT06628570
STUDY00006091
R01CA285198
  • Ages 30-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 30-80 years of age

  • Individuals with chronic impaired immune status

  • History of high-grade lower genital tract neoplasia (LGTN), Zubrod PerformanceStatus of 0-2;

Exclusion

Exclusion Criteria:

  • Patients treated for aHSIL less than 6 months before screening,

  • History of anal cancer and pregnant women.

Study Design

Total Participants: 500
Treatment Group(s): 4
Primary Treatment: Anal Cytology
Phase:
Study Start date:
December 16, 2024
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

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

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

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

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • The Ponce Center

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Grady Memorial Hospital

    Atlanta 4180439, Georgia 4197000 30303
    United States

    Active - Recruiting

  • The Ponce Center

    Atlanta 4180439, Georgia 4197000 30308
    United States

    Active - Recruiting

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