Improving Detection and Early Action for HPV-positive Oropharynx Cancer

Brigham and Women's Hospital40 enrolled

Overview

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

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Interventions

Blood test for HPV DNADIAGNOSTIC_TEST

All participants will have blood tested for HPV DNA.

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Prevalence of circulating HPV DNA

Proportion of participants with circulating HPV DNA detected in their blood.

Time frame: Test results are returned within 1 week.

Secondary Outcomes

Predictive value of circulating HPV DNA

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

HPV-OPC awareness

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

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

Time frame: Within 2-3 weeks of study enrollment

Data from ClinicalTrials.gov

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