Improving Detection and Early Action for HPV-positive Oropharynx Cancer (IDEA-HPV)

Mass General Brigham

Status: Completed

Conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma

Treatments: Diagnostic Test: Blood test for HPV DNA

Study type: Interventional

Funder types: Other

Identifiers

NCT04871490

2020P003370

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Study Group

Other group

Description:

All eligible participants.

Treatment:

Diagnostic Test: Blood test for HPV DNA