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
M.D. Anderson Cancer Center
Summary
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: 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.
Eligibility
- Age range
- 25–49 years
- Sex
- Female
- Healthy volunteers
- No
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
Interventions
- DeviceDeepDOF Images
Women referred for consultation for cervical biopsy(ies) and/or LEEP will be recruited into the experimental group of the study.
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas