Rice Technologies for Cervical Cancer Screening and Diagnosis

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05372484
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Multimodal optical imaging — DEVICE
    Women referred for colposcopy due to abnormal cervical screening will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination.

Study Details

The study aims to compare the accuracy of the lateral flow test to detect HPV at the POC with commercially available HPV test and to determine the diagnostic accuracy and reliability of a multimodal optical imaging system to detect cervical dysplasia, with the gold reference standard of histopathology.

Key Dates

Start date
Mar 24, 2021
Status verified
Feb 2026
Primary completion
Mar 30, 2028
Completion
Mar 30, 2028

Study Design

Enrollment
678 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Multi-Modal Optical Imaging
    Multi-modal imaging (mobile colposcopy and high resolution imaging) of study participants will be performed during the colposcopy examination. Cervical biopsies will be performed using biopsy forceps per standard protocols.

Primary Outcome Measure

Development of multimodal optical imaging system [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Kathleen Schmeler, MD
713-854-9150
Kathleen Schmeler, MD (PRINCIPAL_INVESTIGATOR)

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