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Clinical Trials/NCT05814549
NCT05814549
Active, not recruiting
Not Applicable

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

Memorial Sloan Kettering Cancer Center7 sites in 1 country9 target enrollmentMarch 31, 2023
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ConditionsOropharyngeal CancerHPV-Related CarcinomaHPV Positive Oropharyngeal Squamous Cell Carcinoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oropharyngeal Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
9
Locations
7
Primary Endpoint
Proportion of participants found to have HPV-related OPC
Status
Active, not recruiting
Last Updated
7 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 31, 2023
End Date
March 31, 2031
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Proportion of participants found to have HPV-related OPC

Time Frame: 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).

Study Sites (7)

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