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

Not Applicable

Not yet recruiting

• Conditions: Cervical Cancer; HIV

• Registration Number: NCT06850402
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Study Start: 2025-06-01
• Primary Completion: 2027-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Out Measures	through study completion, an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

The University of Texas M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States