Health Trials

About this trial

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

Qualifiers

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;

Disqualifiers

Patients treated for aHSIL less than 6 months before screening,

History of anal cancer and pregnant women.

Trial design

Treatments tested in this trial

  • HRA + Biopsy
  • Anal Cytology
  • Genotyping of anal hrHPV infection
  • CINtec®PLUS

Treatment groups

500 Participants
are divided into 4 treatment groups

Locations

4
University of Miami Miller School of Medicine-Sylvester Cancer Center33136, MiamiFlorida, United States
University of Miami School of Medicine at Jackson Memorial Hospital (JMH)33136, MiamiFlorida, United States
Grady Memorial Hospital30303, AtlantaGeorgia, United States
The Ponce Center30308, AtlantaGeorgia, United States

Sponsors and collaborators

Lisa Flowers

Lead sponsor

Emory University

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov