Screening Strategies for People With a High Risk of Anal Cancer

Last updated: January 22, 2025
Sponsor: Lisa Flowers
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Anal Dysplasia

Treatment

Genotyping of anal hrHPV infection

CINtec®PLUS

HRA + Biopsy

Clinical Study ID

NCT06628570
STUDY00006091
R01CA285198
  • Ages > 30
  • 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 minorities with a high risk of anal cancer and 2) characterize DNA methylation, immunologic response, and social determinants associated with aHSIL.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 30 years of age and older

  • Identifies as Black or Latinx,

  • Males (MSM only) and females with a known history of high-grade lower genital tractneoplasia (LGTN), Zubrod Performance Status of 0-2;

  • Women with Human Papillomavirus (HPV) related cervical, vaginal, or vulvarhigh-grade precancer or cancer

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: Genotyping of anal hrHPV infection
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 living with HIV. The study is important because the incidence of anal cancer is particularly high among certain groups; health disparity further contributes to this high risk among minorities. Findings will provide much-needed evidence for anal cancer screening strategies to reduce health disparities, improve screening outcomes, and decrease the incidence of anal cancer among high-risk minorities. The study population includes Black or Latinx, males - men having sex with men (MSM) only - 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

  • Grady Memorial Hospital

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • The Ponce Center

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

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