Evaluating a New Microscope for Cervical Cancer Screening

This study is testing a new type of optical microscope called DeepDOF. It aims to see if DeepDOF can produce images of cervical biopsies (tissue samples) and LEEP specimens (tissue removed during a procedure for abnormal cells) that are as good as standard lab tests. The study will compare the DeepDOF images with traditional results to see how well they match. Researchers also want to see if pathologists (doctors who diagnose diseases by looking at tissues) can accurately diagnose using these digital images. The study is enrolling 400 women, aged 25-49, who are having a cervical biopsy or LEEP. Participants will be enrolled in Mozambique and Brazil. The study's status is currently unclear.

Study design
This interventional study plans to enroll 400 women. It will compare the DeepDOF imaging platform with standard histopathology.
What's involved
If you join, your cervical biopsy and/or LEEP specimens will be used for imaging with DeepDOF before standard lab processing. You will need to provide informed consent.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes will be measured throughout the study completion, which is an average of 1 year.

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NCT06850402

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

Recruiting
NAAges 25–49InterventionalDiagnostic
M.D. Anderson Cancer Center
~400 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:DeepDOF Images

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Out Measures
Measured over through study completion, an average of 1 year
Cervical Cancer
HIV
1 sites across 1 states
Texas1
  • Kathleen M Schmeler, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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  • Primary Out Measuresthrough 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