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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06434337
Status
Recruiting

Conditions

  • Human Papillomavirus

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test") — DIAGNOSTIC_TEST
    Given by Diagnostic Test

Study Details

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.

Key Dates

Start date
Jul 23, 2024
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Kathleen Schmeler, MD
713-745-3518
Kathleen Schmeler, MD (PRINCIPAL_INVESTIGATOR)

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