Status:

COMPLETED

Improving Detection and Early Action for HPV-positive Oropharynx Cancer

Lead Sponsor:

Brigham and Women's Hospital

Conditions:

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Eligibility:

All Genders

35+ years

Phase:

NA

Brief Summary

This study aims to determine whether a blood test for HPV DNA can improve diagnosis of HPV-positive oropharynx cancer (HPV-OPC).

Detailed Description

The diagnosis of HPV-OPC is often delayed. In this study, individuals with signs or symptoms potentially related to HPV-OPC, such as unexplained throat pain, tonsil or tongue base asymmetry, or a neck...

Eligibility Criteria

Inclusion

  • Neck mass present for \>2 weeks with no signs/symptoms of infection
  • Neck mass present for \>2 weeks with signs/symptoms of infection that did not resolve with antibiotic therapy
  • Palatine or lingual tonsillar asymmetry on physical exam
  • Palatine or lingual tonsillar asymmetry on imaging, including asymmetric FDG uptake in palatine or lingual tonsils on PET-CT scans
  • Unexplained throat pain for \>2 weeks that did not resolve with antibiotic therapy

Exclusion

  • Known diagnosis of HPV-OPC

Key Trial Info

Start Date :

March 24 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2024

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04871490

Start Date

March 24 2021

End Date

December 31 2024

Last Update

February 5 2025

Active Locations (1)

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1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02130