Improving Detection and Early Action for HPV-positive Oropharynx Cancer

Not Applicable

Completed

• Conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma

• Registration Number: NCT04871490
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2021-03-24
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-04
• Primary Completion: 2022-12-15
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Prevalence of circulating HPV DNA	Test results are returned within 1 week.	Proportion of participants with circulating HPV DNA detected in their blood.

Secondary Outcome Measures

Name	Time	Method
Impact on clinical practice	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
HPV-OPC awareness	At the time of study enrollment	Awareness of HPV-OPC and other HPV-related malignancies among participants will be assessed by a brief survey
Predictive value of circulating HPV DNA	Long-term follow-up for up to 2 years	Proportion of participants with positive circulating HPV DNA for whom HPV-OPC is detected

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States