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Recruiting
NCT06949800
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
Conditions: HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma, Anal HSIL
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 90
Sponsor: University of California, San Francisco
Location: University of California, San Francisco San Francisco California
Summary
This study is focused on treatment of anal high-grade squamous intraepithelial lesions (HSIL) in persons with HIV (PWH), with the ultimate goal of applying the approach toward prevention of anal cancer in this population
Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent
2. Biopsy-proven anal HSIL (men or women) at a screening visit for C2002, or clinic patients with known untreated HSIL diagnosed within the previous 3 months.
4\. At least one focus of anal HSIL must be large enough to be monitored for response, i.e.,not completely removed after the screening biopsy.
5\. Total volume of HSIL is less than 50% of the anal canal or perianal region. 6.Must be actively on treatment with effective antiretroviral therapy (ART) regimen for at least three months preceding enrollment (Visit 1, Day 1) at screening for C2002.
7.HIV RNA \
Source: ClinicalTrials.gov (NCT06949800). StuddyBuddy aggregates publicly available trial information.