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

February 3, 2025 updated by: Eleni M. Rettig, MD, Brigham and Women's Hospital
This study aims to determine whether a blood test for HPV DNA can improve diagnosis of HPV-positive oropharynx cancer (HPV-OPC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study Group
All eligible participants.
Diagnostic test: Blood test for HPV DNA
All participants will have blood tested for HPV DNA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Test results are returned within 1 week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Long-term follow-up for up to 2 years
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
At the time of study enrollment
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
Within 2-3 weeks of study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P003370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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