CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
United States, Puerto Rico90 participantsStarted 2026-06-01
Plain-language 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
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Signed informed consent
✓. Participant in ULACNet-101 or participant screened specifically for ULACNet-102.
✓. Biopsy-proven anal HSIL (men or women) shown as part of participation in the ULACNet-101 study or at a screening visit for ULACNet-102.
✓. 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.
✓. Total volume of HSIL is less than 50% of the anal canal or perianal region.
✓. Must be actively on treatment with effective antiretroviral therapy (ART) regimen for at least three months preceding enrollment (Visit 1, Day 1) in ULACNet-101 or at screening for ULACNet-102.
✓. HIV RNA \<200 copies/ml at baseline.
✓. Cluster of differentiation 4 (CD4) nadir above 200 cells per microliter (uL)
Exclusion criteria
✕. History of any anogenital cancer.
✕. Presence of untreated cervical HSIL or cervical cancer.
✕. Anal HSIL on clinical examination or biopsy that clinicians are concerned for cancer.
✕. Receipt of chemotherapy, radiotherapy or immunosuppressive medication in three months preceding enrollment in ULACNet-101 or at the screening visit for ULACNet-102.
What they're measuring
1
Proportion of participants with no disease present
Timeframe: Up to 36 weeks
2
Proportion of participants reporting treatment-emergent adverse events
✕. Immunosuppression as a result of underlying illness or treatment including:
✕. Use of high dose corticosteroids (\>10 mg/day prednisone or equivalent) for \>=7 days (inhaled, otic, topical and ophthalmic corticosteroids are permitted).
✕. Primary immune deficiency disease.
✕. Use of synthetic or biologic disease-modifying anti-rheumatic drugs.