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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Human Papillomavirus

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

Study type: Observational

Funder types: Other

Identifiers

NCT06434337

2024-0020

NCI-2024-04598 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

600 participants in 1 patient group

Research Group

Description:

Standard-of-care (SOC) procedures will be performed as part of the routine visit, and the provider will collect up to two additional cervical swabs for research. One research cervicovaginal swab may also be self-collected by the patient (optional procedure) in the clinic during the routine visit. All research swab samples, in addition to residual material from standard of care HPV testing, will be transferred to Rice University team for testing and some will be tested on site at the provider facility as described below.

Treatment:

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