This clinical trial compares the accuracy of two types of testing, point-of-care (POC) human papillomavirus (HPV) and standard of care gold standard tests in screening for cervical cancer. Screening with POC and gold standard tests may help doctors find cervical cancer sooner when it may be easier to treat.
Additional locations may be listed on ClinicalTrials.gov for NCT05372484.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Kathleen Marie Schmeler
PRIMARY OBJECTIVES:
I. Analyze the diagnostic agreement between the experimental low-cost lateral flow test to detect human papillomavirus (HPV) in point-of-care (POC) and a standard of care test, comparing the results of both.
II. Determine the diagnostic accuracy and reliability of a multimodal optical imaging system to detect cervical dysplasia, and compare it with histopathology (gold standard).
OUTLINE:
Patients undergo self-collection and healthcare provider HPV testing for analysis via gold standard test, the Rice POC HPV test, and/or stored for future research. Patients may also undergo blood sample collection on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorKathleen Marie Schmeler