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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
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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