Evaluation of a new HPV diagnostic test
Official title: Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
Run by M.D. Anderson Cancer Center · NCT06434337 · Data updated 2026-11-12
This study is testing a new HPV test to see if it works better than regular tests and if people prefer to collect samples themselves or have a provider do it.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years and up |
| Sex | Women only |
| Enrollment | 600 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | July 23, 2024 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | May 18, 2026 |
| Trial ID | NCT06434337 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with a cervix aged 21 years or older who are scheduled for HPV testing or related procedures.
✕Probably not a fit
Patients who are pregnant or those who opt out of HPV testing will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the performance of a novel point-of-care diagnostic test for detecting Human Papillomavirus (HPV), known as the Rice HPV test. It aims to compare the results of this new test with standard HPV tests and assess its effectiveness in detecting high-grade cervical dysplasia. The study also explores how different sample processing and test readout methods impact the test's performance, as well as participant preferences for self-sampling versus provider-collected samples. The findings may lead to more accessible HPV testing options.
Why it matters
Potential benefit: If successful, this study could lead to the development of more accessible and efficient HPV testing methods.
How similar studies have gone: Other studies have shown promise in developing point-of-care diagnostic tests for HPV, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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. Participant or provider decision not to collect a sample for this study. 3. Participants that are pregnant.
Where it's running
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MD Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Kathleen Schmeler, MD — M.D. Anderson Cancer Center
- Study coordinator: Kathleen Schmeler, MD
- Email: kschmele@mdanderson.org
- Phone: (713) 745-3518
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.