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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2028-09-01

Brief Summary

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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.

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Detailed Description

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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

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Cervical Cancer HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DeepDOF Images

Intervention Type DEVICE

Women referred for consultation for cervical biopsy(ies) and/or LEEP will be recruited into the experimental group of the study.

Interventions

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DeepDOF Images

Women referred for consultation for cervical biopsy(ies) and/or LEEP will be recruited into the experimental group of the study.

Intervention Type DEVICE

Eligibility Criteria

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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