Screening Strategies Among High-risk Populations for Anal Cancer
Recruiting · NCT06628570 · Interventional (participants receive a specific treatment) · Lead sponsor: Lisa Flowers
View the official record on ClinicalTrials.gov →Interventions studied
Anal CytologyCINtec®PLUSGenotyping of anal hrHPV infectionHRA + Biopsy
What this trial is about
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.
Who can take part
Age range
30 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 30-80 years of age
- Individuals with chronic impaired immune status
- History of lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2
Exclusion criteria
- Patients treated for aHSIL less than 6 months before screening
- History of anal cancer and pregnant women.
Where it is running
4 locations listed across 2 US states.
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami, Florida, United States
- University of Miami School of Medicine at Jackson Memorial Hospital (JMH) - Miami, Florida, United States
- Grady Memorial Hospital - Atlanta, Georgia, United States
- The Ponce Center - Atlanta, Georgia, United States