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

Human Papillomavirus Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Human Papillomavirus

• NCT number: NCT06434337
• Study type: Observational
• Source: M.D. Anderson Cancer Center
• Contact: Kathleen Schmeler, MD
• Phone: (713) 745-3518
• Email: kschmele@mdanderson.org
• Status: Not yet recruiting
• Start date: November 29, 2024
• Completion date: March 31, 2028