HPV Test for Human Papillomavirus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new HPV test can match the results of standard tests while requiring less equipment, thus increasing accessibility. Participants will provide a few extra cervical swabs during regular HPV testing visits, and some may try a self-swab. Individuals with a cervix scheduled for HPV testing or certain procedures at MD Anderson or Harris Health System are invited to participate. As an unphased trial, this study allows participants to help make HPV testing more accessible and convenient for everyone.
Do I need to stop my current medications for the HPV test trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that this novel point-of-care diagnostic test for detecting HPV is safe?
Research shows that point-of-care tests for HPV, like the one under study, are designed to be safe and easy to use. Similar tests have been comfortable for patients. Studies have found that these tests can be completed quickly, often in less than 90 minutes, reducing discomfort and stress.
No major reports of problems have emerged with similar HPV point-of-care tests, suggesting that this new test is likely safe as well. However, as it is still under evaluation, researchers will continue to monitor its safety and effectiveness.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it tests a novel point-of-care diagnostic method for detecting Human Papillomavirus (HPV). Unlike traditional lab-based HPV tests that can take days to deliver results, this new approach aims to provide faster, on-site results, potentially during the same clinic visit. This method could revolutionize how HPV is diagnosed by making screening more accessible and immediate, especially in resource-limited settings. The trial also explores the convenience of self-collected samples, which could increase patient participation in screening programs.
What evidence suggests that this novel point-of-care diagnostic test is effective for detecting HPV?
This trial will evaluate a novel point-of-care diagnostic test for detecting HPV. Studies have shown that HPV-based screening tests are highly effective, with over 90% accuracy in detecting serious cervical changes. Research indicates that point-of-care tests, which use self-collected samples, have about 85.4% accuracy for identifying severe cervical changes. These tests are designed to be simple and easy to use, allowing screening without complicated equipment. Overall, point-of-care tests for HPV show promise in accuracy and convenience, potentially enhancing early detection and treatment of HPV-related conditions.13678
Who Is on the Research Team?
Kathleen Schmeler, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Sample Collection and Testing
Standard-of-care procedures and additional cervical swabs collected for research; samples tested using the Rice HPV test
Follow-up
Participants are monitored for safety and effectiveness after sample collection and testing
What Are the Treatments Tested in This Trial?
Interventions
- Novel point-of-care diagnostic test for detecting HPV
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Standard-of-care (SOC) procedures will be performed as part of the routine visit, and the provider will collect up to two additional cervical swabs for research. One research cervicovaginal swab may also be self-collected by the patient (optional procedure) in the clinic during the routine visit. All research swab samples, in addition to residual material from standard of care HPV testing, will be transferred to Rice University team for testing and some will be tested on site at the provider facility as described below.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
Point-of-care tests for human papillomavirus detection in ...
Human papillomavirus (HPV)-based screening tests offer a better sensitivity (>90%) for the detection of cervical high-grade lesions.
Evaluation of a Novel Point-of-Care Diagnostic Test for ...
1. To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test"). To evaluate the results of the Rice ...
Point-of-care HPV DNA testing of self-collected specimens ...
The point-of-care self-collect, test, and treat strategy detected underlying HSIL or worse with an estimated 85·4% sensitivity (95% CI 81·0–89·6), 89·6% ...
Evaluation of a Chip-Based, Point-of-Care, Portable, Real- ...
The objective of our study was to evaluate the diagnostic performance of a point-of-care, portable, battery-operated device called Truenat, which detects 4 HR ...
Triple-mode point-of-care diagnostics for high-risk human ...
Direct nucleic acid test (NAT) and nucleic acid amplification test (NAAT) are among the most effective methods for high-risk HPV screening (Mou et al., 2021).
Risk assessment of careHPV testing for the detection ...
The point-of-care testing (POCT) is a new and robust platform for HPV testing that is particularly suitable for promoting HPV testing for primary screening in ...
A novel method for semi-quantitative detection of HPV16 and ...
Her research focuses on developing a point-of-care test to detect HPV mRNA in resource-limited areas to identify patients who are at high risk ...
Point-of-Care (POC) for HPV-related genital cancers
Point-of-Care (POC) or Point-of-Care Testing (POCT) have been generally intended for rapid diagnostic testing (less than 90 minutes) to detect and diagnose ...
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