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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05814549

Enrollment

Registered

2023-04-18

Start date

2023-03-31

Completion date

2031-03-31

Last updated

2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Carcinoma, Oropharyngeal Cancer

Keywords

HPV-Related Oropharyngeal Cancer, Human Papillomavirus, Oropharyngeal Cancer, HPV-Related Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Cell Free Human Papillomavirus Deoxyribonucleic Acid, cf HPV DNA, 22-234, Memorial Sloan Kettering Cancer Center

Brief 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.

Interventions

DIAGNOSTIC_TESTNavDx

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of participants found to have HPV-related OPC	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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026