NCT06850402

Evaluation of a Novel Optical Microscope With a Deep Depth of Field (DeepDOF) to Provide Histologic-quality Images on Cervical Biopsies and Loop Electrosurgical Excision Procedure (LEEP) Specimens at the Point-of-care

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 25 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

All patients will be enrolled in Mozambique and Brazil. They will provide informed consent to use their cervical biopsy and/or LEEP specimens for imaging with DeepDOF prior to sending for standard of care processing and interpretation.

Detailed description

Primary Objectives: 1. Evaluate the diagnostic performance of the DeepDOF digital histopathology platform compared with standard histopathology in cervical biopsies and/or LEEP specimens. 2. Compare performance characteristics between WLWH and HIV-negative women. Secondary Objectives: 1. Evaluate the ability of pathologists to provide a diagnostic evaluation of cervical biopsies and LEEP margins using digital DeepDOF images. 2. Develop DeepDOF algorithms for automated diagnostic evaluation of cervical biopsies and LEEP margins.

Conditions

• Cervical Cancer
• HIV

Interventions

Type	Name	Description
DEVICE	DeepDOF Images	Women referred for consultation for cervical biopsy(ies) and/or LEEP will be recruited into the experimental group of the study.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2025-02-27
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study