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
2 other identifiers
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
Study Completion
Last participant's last visit for all outcomes
September 1, 2028
March 9, 2026
March 1, 2026
1.3 years
February 17, 2025
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Out Measures
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
Study Arms (1)
DeepDOF Images
EXPERIMENTALParticipants 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.
Interventions
Women referred for consultation for cervical biopsy(ies) and/or LEEP will be recruited into the experimental group of the study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women under 25 or over 49 years of age
- Women not undergoing cervical biopsy or LEEP
- Women who are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen M Schmeler, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2025
First Posted
February 27, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2028
Last Updated
March 9, 2026
Record last verified: 2026-03