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NCT05814549 Clinical Trial

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

Oropharyngeal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05814549
Other study ID # 22-234
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 31, 2023
Est. completion date March 31, 2031

Study information
Verified date November 2023
Source Memorial Sloan Kettering Cancer Center
Contact Nancy Lee, MD
Phone 212-639-3341
Email leen2@MSKCC.ORG
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date March 31, 2031
Est. primary completion date March 31, 2031
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) Commack New York
United States Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey
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

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of participants found to have HPV-related OPC : 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). Up to 5 years
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Active, not recruiting NCT03777384 - EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
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Recruiting NCT02984410 - Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma N/A
Recruiting NCT02960724 - uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer Phase 2
Completed NCT02934724 - Impact of HPV Vaccine On The Prevalence Of HPV In Norway
Withdrawn NCT00928161 - Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy N/A
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