DeepDOF imaging for cervical tissue at point-of-care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial will enroll women aged 25-49 undergoing cervical biopsy or LEEP in Mozambique and Brazil. Participants’ tissue samples will be imaged with the DeepDOF system at the point of care and then processed with standard pathology. The study compares DeepDOF image-based diagnoses to conventional histopathology, and also looks at performance differences between WLWH and HIV-negative women. It will also explore how well pathologists can diagnose from DeepDOF images and aims to develop automated DeepDOF algorithms for evaluating biopsies and margins.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Women aged 25 - 49 years
2. women undergoing cervical biopsy and/or LEEP
3. Women who are not pregnant and with a negative pregnancy test (within 3 days of enrollment)
4. Willing and capable of providing informed consent

Exclusion Criteria:

1. Women under 25 or over 49 years of age
2. Women not undergoing cervical biopsy or LEEP
3. Women who are pregnant

Where it's running

• The University of Texas M. D. Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Kathleen M Schmeler, MD — M.D. Anderson Cancer Center
• Study coordinator: Kathleen M Schmeler, MD
• Email: kschmele@mdanderson.org
• Phone: (713) 854-9150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.