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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DeepDOF Images.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, HIV. Basic parameters: 25 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device DeepDOF Images
Women referred for consultation for cervical biopsy(ies) and/or LEEP will be recruited into the experimental group of the study.
Primary outcome measures
- Primary Out Measures [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Women aged 25 - 49 years
- women undergoing cervical biopsy and/or LEEP
- Women who are not pregnant and with a negative pregnancy test (within 3 days of enrollment)
- Willing and capable of providing informed consent
Exclusion criteria
- Women under 25 or over 49 years of age
- Women not undergoing cervical biopsy or LEEP
- Women who are pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- The University of Texas M. D. Anderson Cancer Center — Houston
Identifiers
NCT: NCT06850402 · 2024-2034 · NCI-2025-01257