HPV Positive Oropharyngeal Squamous Cell Carcinoma
Conditions
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.
Interventions
DIAGNOSTIC_TESTBlood test for HPV DNA
All participants will have blood tested for HPV DNA.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of circulating HPV DNA | Test results are returned within 1 week. | Proportion of participants with circulating HPV DNA detected in their blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed