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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
400
Women referred for consultation for cervical biopsy(ies) and/or LEEP will be recruited into the experimental group of the study.
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Primary Out Measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.