Improving Detection and Early Action for HPV-positive Oropharynx Cancer

  • STATUS
    Recruiting
  • End date
    Apr 14, 2025
  • participants needed
    40
  • sponsor
    Brigham and Women's Hospital
Updated on 14 May 2021

Summary

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

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 mass, will have their blood tested for circulating HPV DNA. A positive test may indicate that their symptoms are caused by HPV-OPC, and their treating physician will be encouraged to complete all the necessary testing to determine whether this is the case.

Details
Condition HPV Positive Oropharyngeal Squamous Cell Carcinoma
Treatment Blood test for HPV DNA
Clinical Study IdentifierNCT04871490
SponsorBrigham and Women's Hospital
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

Known diagnosis of HPV-OPC
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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