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NCT06850402NARecruiting

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

M.D. Anderson Cancer Center

Start Date

9/22/2025

Completion Date

9/1/2028

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.

Eligibility Criteria

Age Range: 25 years to 49 years

Inclusion Criteria: 1. Women aged 25 - 49 years 2. women undergoing cervical biopsy and/or LEEP 3. Women who are not pregnant and with a negative pregnancy test (within 3 days of enrollment) 4. Willing and capable of providing informed consent Exclusion Criteria: 1. Women under 25 or over 49 years of age 2. Women not undergoing cervical biopsy or LEEP 3. Women who are pregnant

Interventions

DEVICE

DeepDOF Images

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Conditions

Cervical CancerHIV

Locations

The University of Texas M. D. Anderson Cancer Center

Houston, Texas 77030

United States