Human Papillomavirus
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTNovel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
Given by Diagnostic Test
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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 OR are anticipated to undergo a LEEP, ECC, or biopsy. 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. Patient or provider decision not to perform HPV testing. This does not apply to patients that are undergoing either a LEEP, ECC or biopsy. 2. Participant or provider decision not to collect a sample for this study. 3. Participants that are pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test") | Through study completion; an average of 1 year | To evaluate the performance of the 3 version of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test"). |
Countries
United States
Contacts
CONTACTKathleen Schmeler, MD
PRINCIPAL_INVESTIGATORKathleen Schmeler, MD
M.D. Anderson Cancer Center
Outcome results
None listed