Screening methods for high-risk anal cancer patients
Screening Strategies Among High-risk Populations for Anal Cancer
This study is testing new ways to screen for early signs of anal cancer in high-risk people, especially those living with HIV, to help improve their health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 4 sites (Miami, Florida and 3 other locations) |
| Trial ID | NCT06628570 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate new screening techniques for anal high-grade squamous intraepithelial lesions (aHSIL), a precursor to anal cancer, particularly among minorities at high risk. The study focuses on individuals living with HIV, as they face a higher incidence of anal cancer. Participants will complete self-reported questionnaires and provide biosamples for analysis, which will help identify social determinants and biological factors associated with aHSIL. The findings are expected to inform better screening strategies and reduce health disparities in anal cancer outcomes.
Who should consider this trial
Good fit: Ideal candidates include Black or Latinx individuals aged 30 and older, specifically males who have sex with men (MSM) and females with a history of high-grade lower genital tract neoplasia.
Not a fit: Patients who have been treated for aHSIL within the last 6 months, those with a history of anal cancer, and pregnant women may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening strategies that significantly reduce the incidence of anal cancer among high-risk populations.
How similar studies have performed: Other studies have shown success in screening approaches for HPV-related cancers, but this specific focus on high-risk minorities is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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; Exclusion Criteria: * Patients treated for aHSIL less than 6 months before screening, * History of anal cancer and pregnant women.
Where this trial is running
Miami, Florida and 3 other locations
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (Recruiting)
- University of Miami School of Medicine at Jackson Memorial Hospital (JMH) — Miami, Florida, United States (Recruiting)
- Grady Memorial Hospital — Atlanta, Georgia, United States (Recruiting)
- The Ponce Center — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Flowers, MD, MPH — Emory University
- Study coordinator: Lisa Flowers, MD, MPH
- Email: lflowe2@emory.edu
- Phone: 404-251-8931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.