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
Sponsored by M.D. Anderson Cancer Center
About this study
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.
Primary Objectives: 1. Evaluate the diagnostic performance of the DeepDOF digital histopathology platform compared with standard histopathology in cervical biopsies and/or LEEP specimens. 2. Compare performance characteristics between WLWH and HIV-negative women. Secondary Objectives: 1. Evaluate the ability of pathologists to provide a diagnostic evaluation of cervical biopsies and LEEP margins using digital DeepDOF images. 2. Develop DeepDOF algorithms for automated diagnostic evaluation of cervical biopsies and LEEP margins.
Where this study is enrolling
- I'm interested
The University of Texas M. D. Anderson Cancer Center
Houston, Texas
Who can participate
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
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Trial data sourced from ClinicalTrials.gov.