Recruiting

DeepDOF

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06850402

Conditions

Cervical Cancer

HIV

Eligibility Criteria

Sex: Female

Age: 25 - 49

Healthy Volunteers: Not accepted

Interventions

DeepDOF Images

Study Details

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.

Conditions

Cervical Cancer

HIV

Study ID

NCT06850402

Start date

Sep 22, 2025

Status verified date

Mar, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 49

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: DeepDOF Images

Participants will be approached by a trained research assistant. After informed consent is obtained, each participant will collect two cervical swabs (self-collected and/or provider-collected) as an optional procedure and stored for future research. VIA and/or colposcopy will be performed per standard of care. Cervical biopsy(ies) and/or LEEP will be performed per standard of care. The specimens will be imaged immediately using DeeDOF at the point of care and then submitted for standard histopathologic analysis as shown in Figure 1.

Interventions

DeepDOF Images

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

Primary outcome measure

  • Primary Out Measures [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Kathleen M Schmeler, MD

(713) 854-9150kschmele@mdanderson.org

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Kathleen M Schmeler, MD

713-854-9150kschmele@mdanderson.org

Principal Investigator:

Kathleen M Schmeler, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 18, 2026

Last verified

Mar, 2026

Keywords

  • HPV DNA Testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-18.