Overview
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.
Description
Primary Objectives:
- Evaluate the diagnostic performance of the DeepDOF digital histopathology platform compared with standard histopathology in cervical biopsies and/or LEEP specimens.
- Compare performance characteristics between WLWH and HIV-negative women.
Secondary Objectives:
- Evaluate the ability of pathologists to provide a diagnostic evaluation of cervical biopsies and LEEP margins using digital DeepDOF images.
- Develop DeepDOF algorithms for automated diagnostic evaluation of cervical biopsies and LEEP margins.
Eligibility
Inclusion Criteria:
- Women aged 25 - 49 years
- women undergoing cervical biopsy and/or LEEP
- Women who are not pregnant and with a negative pregnancy test (within 3 days of enrollment)
- Willing and capable of providing informed consent
Exclusion Criteria:
- Women under 25 or over 49 years of age
- Women not undergoing cervical biopsy or LEEP
- Women who are pregnant
