Recruiting

HPV Diagnostic Test

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06434337

Conditions

Human Papillomavirus

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06434337

Start date

Jul 23, 2024

Status verified date

May, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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

Given by Diagnostic Test

Primary outcome measure

  • Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test") [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Kathleen Schmeler, MD

(713) 745-3518kschmele@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Kathleen Schmeler, MD

713-745-3518kschmele@mdanderson.org

Principal Investigator:

Kathleen Schmeler, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-18.