Screening Strategies Among High-risk Populations for Anal Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorLisa Flowers

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

Sponsors and collaborators

Lisa Flowers

Lead sponsor

Emory University

Sponsor institution

National Cancer Institute (NCI)

Collaborator