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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434337
• Other study ID #: 2024-0020
• Secondary ID: NCI-2024-04598
• Status: Not yet recruiting
• Start date: November 29, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Kathleen Schmeler, MD
• Phone: (713) 745-3518
• Email: kschmele[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

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. Participant or provider decision not to perform HPV testing.

2. Participant or provider decision not to collect a sample for this study.

3. Participants that are pregnant.

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

Diagnostic Test:
• Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
Given by Diagnostic Test

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")	To evaluate the performance of the 3 version of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").	Through study completion; an average of 1 year

External Links

•   MD Anderson Cancer Center