The Effectiveness of High Resolution Microendoscopy for People Living With HIV
Status:
Completed
Trial end date:
2024-03-28
Target enrollment:
Participant gender:
Summary
The investigators have developed a portable, battery-operated, mobile high-resolution
microendoscope (mHRME) that provides subcellular images of the anal epithelium, delineating
the cellular and morphologic changes associated with neoplasia. The investigators' central
hypothesis is that this 'optical' approach will increase the efficiency, clinical impact, and
cost-effectiveness of the current standard of high-resolution anoscopy(HRA)-guided biopsy,
thus facilitating usage by less-experienced clinicians in community-based or low-resource
settings. To validate this, the investigators will conduct a study to determine the
efficiency and diagnostic characteristics of the mHRME 'optical biopsy' approach versus the
current standard of HRA-based tissue biopsy. Successful results will allow for improved
efficacy and resource utilization for cancer screening in people living with HIV for anal
cancer and other epithelial cancers including the cervix, oral cavity, bladder, and GI tract.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Icahn School of Medicine at Mount Sinai M.D. Anderson Cancer Center Medical University of South Carolina The University of Texas Health Science Center, Houston University of California, San Francisco William Marsh Rice University