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Trial Title:
A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC)
NCT ID:
NCT05814549
Condition:
Oropharyngeal Cancer
HPV-Related Carcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Squamous Cell Carcinoma of Head and Neck
Conditions: 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
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
NavDx
Description:
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.
Arm group label:
No previous history of diagnosed HPV-related head and neck cancer
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
45 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Facility:
Name:
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Start date:
March 31, 2023
Completion date:
March 31, 2031
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05814549
http://www.mskcc.org
