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

March 5, 2026 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas M. D. Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen M Schmeler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DeepDOF Images
Participants will be approached by a trained research assistant. After informed consent is obtained, each participant will collect two cervical swabs (self-collected and/or provider-collected) as an optional procedure and stored for future research. VIA and/or colposcopy will be performed per standard of care. Cervical biopsy(ies) and/or LEEP will be performed per standard of care. The specimens will be imaged immediately using DeeDOF at the point of care and then submitted for standard histopathologic analysis as shown in Figure 1.
Device: DeepDOF Images
Women referred for consultation for cervical biopsy(ies) and/or LEEP will be recruited into the experimental group of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Out Measures
Time Frame: 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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Kathleen M Schmeler, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-2034
  • NCI-2025-01257 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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