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

Recruiting

• Conditions: Oropharyngeal Cancer; HPV-Related Carcinoma; HPV Positive Oropharyngeal Squamous Cell Carcinoma
• Interventions: Diagnostic Test: NavDx

• Registration Number: NCT05814549
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-31
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2031-03-31
• Study Completion: 2031-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No previous history of diagnosed HPV-related head and neck cancer	NavDx	Participants have no previous history of diagnosed HPV-related head and neck cancer

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (7)

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

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States