Clinical trial NCT05814549: A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC)
Official title: A Study of Using Plasma Circulating Cell Free Human Papillomavirus Deoxyribonucleic Acid to Screen (cf HPV DNA) for HPV-Related Oropharyngeal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oropharyngeal Cancer
HPV-Related Carcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 600
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research participants will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC). If the investigator is a member of the treatment team, s/he will screen their participant's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential participants contacted by their treating physician will be referred to the investigator/research staff of the study

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.


Eligibility 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

Primary outcomes:
measure: Proportion of participants found to have HPV-related OPC
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nancy Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: