Back to resultsImproving Detection and Early Action for HPV-positive Oropharynx Cancer (IDEA-HPV)
Primary Purpose
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood test for HPV DNA
Sponsored by
About this trial
This is an interventional diagnostic trial for HPV Positive Oropharyngeal Squamous Cell Carcinoma
Eligibility 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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study Group
Arm Description
All eligible participants.
Outcomes
Primary Outcome Measures
Prevalence of circulating HPV DNA
Proportion of participants with circulating HPV DNA detected in their blood.
Secondary Outcome Measures
Predictive value of circulating HPV DNA
Proportion of participants with positive circulating HPV DNA for whom HPV-OPC is detected
HPV-OPC awareness
Awareness of HPV-OPC and other HPV-related malignancies among participants will be assessed by a brief survey
Impact on clinical practice
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
Full Information
NCT ID
NCT04871490
First Posted
April 29, 2021
Last Updated
March 29, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04871490
Brief Title
Improving Detection and Early Action for HPV-positive Oropharynx Cancer
Acronym
IDEA-HPV
Official Title
Improving Detection and Early Action for HPV-positive Oropharynx Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Positive Oropharyngeal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Other
Arm Description
All eligible participants.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood test for HPV DNA
Intervention Description
All participants will have blood tested for HPV DNA.
Primary Outcome Measure Information:
Title
Prevalence of circulating HPV DNA
Description
Proportion of participants with circulating HPV DNA detected in their blood.
Time Frame
Test results are returned within 1 week.
Secondary Outcome Measure Information:
Title
Predictive value of circulating HPV DNA
Description
Proportion of participants with positive circulating HPV DNA for whom HPV-OPC is detected
Time Frame
Long-term follow-up for up to 2 years
Title
HPV-OPC awareness
Description
Awareness of HPV-OPC and other HPV-related malignancies among participants will be assessed by a brief survey
Time Frame
At the time of study enrollment
Title
Impact on clinical practice
Description
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
Time Frame
Within 2-3 weeks of study enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Improving Detection and Early Action for HPV-positive Oropharynx Cancer
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