A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Oropharyngeal Cancer HPV Positive Oropharyngeal Squamous Cell Carcinoma HPV-Related Carcinoma Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NavDx

Diagnostic Test

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.

Primary outcomes

Proportion of participants found to have HPV-related OPC

Time frame: Up to 5 years

: The primary objective is to determine the feasibility of screening by estimating the yield (proportion of subjects found to have HPV-related OPC out of all subjects screened).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Study of Using Plasma Circulating Cell Free Human Papillomavirus Deoxyribonucleic Acid to Screen (cf HPV DNA) for HPV-Related Oropharyngeal Cancer

Important dates

Study start: 2023
Primary completion: 2031
Study completion: 2031
First posted: Apr 18, 2023
Registry last updated: Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Not Yet Recruiting