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

NCT06434337 | Recruiting

• 2 other identifiers: 2024-0020NCI-2024-04598
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Research Group

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.

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

Interventions

Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test") DIAGNOSTIC_TEST

Given by Diagnostic Test

Research Group

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MD Anderson Cancer Center

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

Study Officials

• Kathleen Schmeler, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Schmeler, MD

CONTACT

(713) 745-3518; kschmele@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: July 23, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)