Improving Detection and Early Action for HPV-positive Oropharynx Cancer

HPV Positive Oropharyngeal Squamous Cell Carcinoma Clinical Trial

— IDEA-HPV  

Official title:

Improving Detection and Early Action for HPV-positive Oropharynx Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04871490
• Other study ID #: 2020P003370
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HPV Positive Oropharyngeal Squamous Cell Carcinoma
• Oropharyngeal Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Diagnostic Test:
• Blood test for HPV DNA
All participants will have blood tested for HPV DNA.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of circulating HPV DNA	Proportion of participants with circulating HPV DNA detected in their blood.	Test results are returned within 1 week.
Secondary	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
Secondary	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
Secondary	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