Evaluation of a new HPV diagnostic test
Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
M.D. Anderson Cancer Center · NCT06434337
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 |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06434337 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with a cervix aged 21 years or older who are scheduled for HPV testing or related procedures.
Not a fit: Patients who are pregnant or those who opt out of HPV testing will not benefit from this study.
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 performed: Other studies have shown promise in developing point-of-care diagnostic tests for HPV, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Human Papillomavirus