Improving Detection and Early Action for HPV-positive Oropharynx Cancer

NCT ID: NCT04871490

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-24

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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HPV Positive Oropharyngeal Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Group

All eligible participants.

Group Type OTHER

Blood test for HPV DNA

Intervention Type DIAGNOSTIC_TEST

All participants will have blood tested for HPV DNA.

Interventions

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Blood test for HPV DNA

All participants will have blood tested for HPV DNA.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eleni M. Rettig, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2020P003370

Identifier Type: -

Identifier Source: org_study_id

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