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NCT Number: NCT06850402

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

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location contact

Kathleen M Schmeler, MD

CONTACT

[email protected]

713-854-9150

Kathleen M Schmeler, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DeepDOF Images

Device

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

Primary outcomes

  1. Primary Out Measures

    Time frame: through study completion, an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen M Schmeler, MD

CONTACT

[email protected]

(713) 854-9150

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 27, 2025
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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