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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06850402
Enrollment
400
Registered
2025-02-27
Start date
2025-09-22
Completion date
2028-09-01
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, HIV

Keywords

HPV DNA Testing

Brief 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.

Detailed 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.

Interventions

DEVICEDeepDOF Images

Women referred for consultation for cervical biopsy(ies) and/or LEEP will be recruited into the experimental group of the study.

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 49 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Primary Out Measuresthrough study completion, an average of 1 yearIncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Countries

United States

Contacts

CONTACTKathleen M Schmeler, MD
kschmele@mdanderson.org(713) 854-9150
PRINCIPAL_INVESTIGATORKathleen M Schmeler, MD

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026