NCT04563754CompletedPhase 1/2
The Effectiveness of High Resolution Microendoscopy for People Living With HIV
The Effectiveness of High Resolution Microendoscopy (HRME) in High Grade Intraepithelial Lesions (HSIL) Diagnosis for People Living With HIV
Source: ClinicalTrials.gov · Last updated 23 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 163 (actual)
- First submitted
- 10 Mar 2020
- Start date
- 30 Jul 2019
- Primary completion date
- 28 Mar 2024
- Lead sponsor
- Baylor College of Medicine
- Diseases
- HIV
- NCT number
- NCT04563754
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 163
- From 30 Jul 2019 to the primary completion date, 28 Mar 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Allergy or prior reaction to the fluorescent contrast agent Proflavine or Iodine
Other illness
- Current or prior history of Invasive Anal Cancer
- Known permanent or irreversible bleeding disorder, or other hematologic disorder that in the opinion of the investigator would place the patient at increased risk for adverse outcome from the procedure
Other
- Unable to undergo routine anoscopy
- Unable to give informed consent
- Pregnancy
Who the study is looking for
- Consentable patients with documented HIV disease
- Either: 1) previously documented HSIL or 2) abnormal anal cytology within the past 2 years
- Ages 18 years and older
- Seen at the Baylor-affiliated Thomas Street Clinic (TSC), Mount Sinai Hospital and affiliated clinics
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.