NCT04871490

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

April 29, 2021

Last Update Submit

February 3, 2025

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Prevalence of circulating HPV DNA

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

    Test results are returned within 1 week.

Secondary Outcomes (3)

  • Predictive value of circulating HPV DNA

    Long-term follow-up for up to 2 years

  • HPV-OPC awareness

    At the time of study enrollment

  • Impact on clinical practice

    Within 2-3 weeks of study enrollment

Study Arms (1)

Study Group

OTHER

All eligible participants.

Diagnostic Test: Blood test for HPV DNA

Interventions

Blood test for HPV DNADIAGNOSTIC_TEST

All participants will have blood tested for HPV DNA.

Study Group

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known diagnosis of HPV-OPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 4, 2021

Study Start

March 24, 2021

Primary Completion

December 15, 2022

Study Completion

December 31, 2024

Last Updated

February 5, 2025

Record last verified: 2025-02

Locations

US(1)