A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC)
NCT05814549 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 9
Last updated 2025-09-19
Summary
The researchers think that a blood test (NavDx®) may be able to identify cancer early by looking for circulating DNA from Human Papillomavirus/HPV. Circulating DNA are small pieces of genes that are released into the bloodstream. The purpose of this study is to find out whether using this blood test to test for HPV DNA will help detect HPV-related Oropharyngeal Cancer/OPC.
Conditions
- Oropharyngeal Cancer
- HPV-Related Carcinoma
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
Interventions
- DIAGNOSTIC_TEST
-
NavDx
Evaluation of HPV presence via NavDx (v1) at two (or three) timepoints o If one of the two blood samples is positive, the subject will have a third NavDx (v1) test approximately 1 month after the second timepoint. If the test is positive, the subject will move to surveillance phase.
Sponsors & Collaborators
-
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Nancy Lee, MD · Memorial Sloan Kettering Cancer Center
Eligibility
- Min Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-03-31
- Primary Completion
- 2031-03-31
- Completion
- 2031-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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