Improving Detection and Early Action for HPV-positive Oro... | NCT04871490

Studies
Improving Detection and Early Action for HPV-positive Oropharynx Cancer

NCT04871490

Sponsor

Brigham and Women's Hospital

Status

Completed

Last Update Posted

Feb 5, 2025Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Interventions

Blood test for HPV DNA

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 24, 2021Actual

Primary Completion Date

Dec 15, 2022Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Apr 29, 2021

First Submission Date that Met QC Criteria

Apr 29, 2021

First Posted Date

May 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2025

Last Update Posted Date

Feb 5, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eleni M. Rettig, MD, Principal Investigator, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Other	All eligible participants.	Diagnostic Test: Blood test for HPV DNA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood test for HPV DNA	Diagnostic Test	All participants will have blood tested for HPV DNA.	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
HPV-OPC awareness	Awareness of HPV-OPC and other HPV-related malignancies among participants will be assessed by a brief survey

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02130	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided