Using blood tests to detect HPV-related throat cancer
A Study of Using Plasma Circulating Cell Free Human Papillomavirus Deoxyribonucleic Acid to Screen (cf HPV DNA) for HPV-Related Oropharyngeal Cancer
This study is testing if a blood test can help find HPV-related throat cancer earlier in people aged 45 and older who have certain sexual histories.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05814549 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a blood test called NavDx® in detecting HPV-related oropharyngeal cancer (OPC) by identifying circulating HPV DNA in the bloodstream. Participants will be individuals aged 45 and older with a specific sexual history, and the study will assess whether this blood test can lead to earlier detection of cancer. The research focuses on those without a prior diagnosis of HPV-related head and neck cancer, making it a targeted approach to identifying at-risk individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 45 and older with a history of multiple sexual partners and oral sexual activity.
Not a fit: Patients with a previous diagnosis of HPV-related oropharyngeal cancer or those younger than 45 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable earlier detection of HPV-related oropharyngeal cancer, potentially improving treatment outcomes.
How similar studies have performed: While the use of blood tests for cancer detection is an emerging field, this specific approach using HPV DNA testing for oropharyngeal cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 45 and older * Self-reported history of four or more lifetime sexual partners * Self-reported history of one or more lifetime oral sexual partner * No previous history of diagnosed HPV-related head and neck cancer Exclusion Criteria: * History of diagnosed HPV-related OPC * Less than three sexual partners in lifetime * No history of oral sex performed * Younger than age 45
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Nancy Lee, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Nancy Lee, MD
- Email: leen2@MSKCC.ORG
- Phone: 212-639-3341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.