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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of California, San Francisco

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • EXE-346 Probiotic
  • Placebo
  • Usual Care High Resolution Anoscopy (HRA)

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

Exegi Pharma, LLC

Collaborator

National Cancer Institute (NCI)

Collaborator