NCT06434337

Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 performance of the Rice HPV test between provider-collected and self-collected samples. 2. Conduct a survey on participant experiences with self-sampling to assess whether participants prefer self-sampling over provider-collected sampling. 3. Compare the performance of the Rice HPV test to other benchmark HPV tests such as GeneXpert.

Conditions

• Human Papillomavirus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")	Given by Diagnostic Test

Timeline

• Start date: 2024-07-23
• Primary completion: 2026-03-31
• Completion: 2028-03-31
• First posted: 2024-05-30
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States