Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").
- Who it may be relevant to
- Registry conditions: Human Papillomavirus. Basic parameters: from 21 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
Given by Diagnostic Test
Primary outcome measures
- Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test") [Time frame: Through study completion; an average of 1 year]
Eligibility criteria
Inclusion criteria
- People with a cervix 21 years of age or older.
- 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.
- Willing and able to provide informed consent.
- Able to perform protocol-required activities. Able to speak and read English or Spanish.
Exclusion criteria
- Patient or provider decision not to perform HPV testing. This does not apply to patients that are undergoing either a LEEP, ECC or biopsy.
- Participant or provider decision not to collect a sample for this study.
- Participants that are pregnant.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06434337 · 2024-0020 · NCI-2024-04598