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CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial

StatusRecruiting
PhasePhase 2
Started2026-09-04
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later across 2 updates Apr 30, 2027 → Oct 31, 2027
See other at-risk trials from University of California, San Francisco

Amendment history

2026-09-11
Study Identification, Study Status v7
Primary completion pushed: 2027-05-31 → 2027-10-31
Completion pushed: 2027-07-31 → 2028-05-31
2026-09-08
Study Status, Contacts/Locations v6
Recruitment opened
Start dateestimated 2026-09-01→confirmed 2026-09-04
Study sitesdetails revised at 2 of 2 sites
2026-07-13
Study Status v5
Primary completion pushed: 2027-04-30 → 2027-05-31
Completion pushed: 2027-05-31 → 2027-07-31
Start date2026-06-01→2026-09-01
2026-04-29
Study Status v4
Primary completion pushed: 2026-12-31 → 2027-04-30
Completion pushed: 2026-12-31 → 2027-05-31
Start date2026-03-15→2026-06-01
2026-01-29
Study Identification, Study Status, Contacts/Locations v3
Primary completion date2026-10-31→2026-12-31
Completion date2026-10-31→2026-12-31
Start date2025-12-01→2026-03-15
Study sites2 entries, revised
InstitutoUniversity Nacionalof deCalifornia, CancerologiaSan Francisco
Study title+14 characters
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
Show 2 earlier versions
2025-11-07
Study Status v2
Start date2025-09-01→2025-12-01
2025-07-11
Study Status, Oversight v1
Primary completion date2026-08-31→2026-10-31
Completion date2026-08-31→2026-10-31
Start date2025-05-16→2025-09-01
2025-04-22
Original filing
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
Trial Details
NCT Number NCT06949800
Lead Sponsor University of California, San Francisco
Collaborators: Exegi Pharma, LLC, National Cancer Institute (NCI)
Conditions HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma, Anal HSIL
Enrollment 90 participants
Start Date 2026-09-04
Primary Completion 2027-10-31 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-15