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Improving Detection and Early Action for HPV-positive Oropharynx Cancer (IDEA-HPV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04871490
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Eleni M. Rettig, MD, Brigham and Women's Hospital

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

Condition or disease Intervention/treatment Phase
HPV Positive Oropharyngeal Squamous Cell Carcinoma Diagnostic Test: Blood test for HPV DNA Not Applicable

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 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improving Detection and Early Action for HPV-positive Oropharynx Cancer
Actual Study Start Date : March 24, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Study Group
All eligible participants.
 Diagnostic Test: Blood test for HPV DNA
All participants will have blood tested for HPV DNA.


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of circulating HPV DNA [ Time Frame: Test results are returned within 1 week. ]
    Proportion of participants with circulating HPV DNA detected in their blood.


Secondary Outcome Measures :
  1. Predictive value of circulating HPV DNA [ Time Frame: Long-term follow-up for up to 2 years ]
    Proportion of participants with positive circulating HPV DNA for whom HPV-OPC is detected

  2. HPV-OPC awareness [ Time Frame: At the time of study enrollment ]
    Awareness of HPV-OPC and other HPV-related malignancies among participants will be assessed by a brief survey

  3. Impact on clinical practice [ Time Frame: Within 2-3 weeks of study enrollment ]
    The proportion of participants for whom clinicla management by the treating clinician is affected by results of the blood test will be measured by a survey sent to treating clinicials


Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871490


Contacts
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Contact: Eleni Rettig, MD 617-632-3643 emrettig@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02130
Contact: Eleni Rettig, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
More Information
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Responsible Party: Eleni M. Rettig, MD, Head & Neck Surgeon, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04871490    
Other Study ID Numbers: 2020P003370
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Oropharyngeal Neoplasms
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases