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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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
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kathleen M Schmeler, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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What this trial measures
- 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