Improving Detection and Early Action for HPV-positive Oropharynx Cancer

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

Detailed Description
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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.

Official Title
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Improving Detection and Early Action for HPV-positive Oropharynx Cancer

Conditions
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HPV Positive Oropharyngeal Squamous Cell Carcinoma

Intervention / Treatment
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* Diagnostic Test: Blood test for HPV DNA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Group<br>All eligible participants. | Diagnostic Test: Blood test for HPV DNA<br>* All participants will have blood tested for HPV DNA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of circulating HPV DNA | 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 | 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 | 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 | 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 |