Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
M.D. Anderson Cancer Center
Summary
To learn if new HPV tests can provide the same results as standard HPV tests. The findings from this study may aid in the development of new HPV tests that require less equipment and are more accessible.
Description
Primary Objectives 1\. To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test"). Secondary Objectives 1. To evaluate the results of the Rice HPV test with corresponding pathology results to assess the association of HPV test results with the presence of high-grade cervical dysplasia (CIN 2+). 2. To assess how different sample processing methods affect the performance of the Rice HPV test. 3. To assess how different test readout methods affect the performance of the Rice HPV test. Exploratory Objectives 1. Compare the performanc…
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. People with a cervix 21 years of age or older. 2. Scheduled to undergo hrHPV testing at MD Anderson and The Harris Health System (LBJ Hospital) according to national and institutional guidelines at time of enrollment OR are anticipated to undergo a LEEP, ECC, or biopsy. 3. Willing and able to provide informed consent. 4. Able to perform protocol-required activities. Able to speak and read English or Spanish. Exclusion Criteria 1. Patient or provider decision not to perform HPV testing. This does not apply to patients that are undergoing either a LEEP, ECC or biopsy. 2…
Interventions
- Diagnostic TestNovel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
Given by Diagnostic Test
Location
- MD Anderson Cancer CenterHouston, Texas