Screening Strategies Among High-risk Populations for Anal Cancer
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: t
View:
• 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;
Locations
United States
Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING
Miami
University of Miami School of Medicine at Jackson Memorial Hospital (JMH)
RECRUITING
Miami
Georgia
Grady Memorial Hospital
RECRUITING
Atlanta
The Ponce Center
RECRUITING
Atlanta
Contact Information
Primary
Lisa Flowers, MD, MPH
lflowe2@emory.edu
404-251-8931
Time Frame
Start Date: 2024-12-16
Estimated Completion Date: 2027-10
Participants
Target number of participants: 500
Treatments
Other: Men with impaired immune status
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
Other: Men without impaired immune status
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
Other: Women with impaired immune status and high grade LGTN
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
Other: Women without impaired immune status with high grade LGTN
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
Related Therapeutic Areas
Sponsors
Leads: Lisa Flowers
Collaborators: National Cancer Institute (NCI)