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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06850402
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Primary Out Measures [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Kathleen M Schmeler, MD
[email protected]
713-854-9150
Kathleen M Schmeler, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Cervical cancerHIV
By specialty
OncologyGynecologic oncologyWomen's healthInfectious disease
By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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