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Completed

NCT Number: NCT04871490

Improving Detection and Early Action for HPV-positive Oropharynx Cancer

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

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Key information

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood test for HPV DNA

Diagnostic Test

All participants will have blood tested for HPV DNA.

Primary outcomes

  1. Prevalence of circulating HPV DNA

    Time frame: Test results are returned within 1 week.

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

Secondary outcomes

  1. Predictive value of circulating HPV DNA

    Time frame: Long-term follow-up for up to 2 years

    Proportion of participants with positive circulating HPV DNA for whom HPV-OPC is detected

  2. HPV-OPC awareness

    Time frame: At the time of study enrollment

    Awareness of HPV-OPC and other HPV-related malignancies among participants will be assessed by a brief survey

  3. Impact on clinical practice

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: IDEA-HPV

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
May 4, 2021
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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