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Diagnostic Test

HPV DNA Blood Test for Oropharyngeal Cancer (IDEA-HPV Trial)

N/A
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Palatine or lingual tonsillar asymmetry on physical exam
Neck mass present for more than 2 weeks with signs/symptoms of infection that did not resolve with antibiotic therapy
Must not have
Known diagnosis of HPV-OPC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up long-term follow-up for up to 2 years
Awards & highlights

Summary

This trial will test whether a blood test for HPV DNA can help doctors better diagnose HPV-positive oropharynx cancer.

Who is the study for?
This trial is for individuals with symptoms like a neck mass, unexplained throat pain lasting more than two weeks, or tonsillar asymmetry without signs of infection. It's not open to those who already have a confirmed diagnosis of HPV-positive oropharyngeal cancer.Check my eligibility
What is being tested?
The study is testing if a blood test for HPV DNA can help in the early detection and diagnosis of HPV-positive cancers in the throat area known as oropharynx cancer.See study design
What are the potential side effects?
Since this trial involves only a blood test for detecting HPV DNA, there are minimal side effects which may include slight pain or bruising at the needle insertion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
One of my tonsils is larger than the other.
Select...
I have had a neck lump for over 2 weeks that didn't improve with antibiotics.
Select...
I have had throat pain for over 2 weeks that antibiotics didn't help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with HPV-related oropharyngeal cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~long-term follow-up for up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and long-term follow-up for up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prevalence of circulating HPV DNA
Secondary outcome measures
HPV-OPC awareness
Impact on clinical practice
Predictive value of circulating HPV DNA

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study GroupExperimental Treatment1 Intervention
All eligible participants.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,628 Previous Clinical Trials
11,474,600 Total Patients Enrolled

Media Library

Blood test for HPV DNA (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04871490 — N/A
Oropharyngeal Carcinoma Research Study Groups: Study Group
Oropharyngeal Carcinoma Clinical Trial 2023: Blood test for HPV DNA Highlights & Side Effects. Trial Name: NCT04871490 — N/A
Blood test for HPV DNA (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04871490 — N/A
~9 spots leftby Jul 2025
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