Post-treatment Surveillance in HPV+ Oropharyngeal SCC

June 13, 2025 updated by: Eleni Marie Rettig, MD, Dana-Farber Cancer Institute

Circulating HPV DNA for Post-treatment Surveillance in HPV-positive Oropharyngeal Squamous Cell Carcinoma

In this research study the investigators are examining a blood test to detect HPV DNA in the blood that can possibly detect cancer recurrence earlier than with standard surveillance measures.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This research study involves blood tests to detect HPV DNA at regular time points after treatment for HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC). Participants may undergo scans based on the results of the blood tests. Study participants will also be asked to complete quality of life questionnaires periodically.

Participation in this study may last for up to 3 years. It is expected that about 150 people will take part in this research study.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Individuals with HPV-positive oropharynx cancer undergoing curative-intent treatment.

Description

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed incident or recurrent squamous cell carcinoma of the tonsil or base of tongue (oropharynx) - includes biopsy of any lymph node with clinical evidence of an oropharynx tumor (unknown primary carcinoma in an involved cervical neck lymph node is permitted if high-risk HPV testing is positive on the involved node)
  • HPV-associated tumor as defined by one or more : positive p16 immunohistochemistry (>70%) OR in situ hybridization OR PCR-based methods
  • Age 18 years or older
  • Will undergo oropharyngeal cancer treatment with curative intent
  • Ability to understand and the willingness to sign a written informed consent document.
  • Baseline positive or detectable ctHPV DNA result in plasma OR detectable corresponding HPV DNA in tumor tissue prior to treatment

Exclusion Criteria:

  • Distant metastatic disease (M1, AJCC 8th edition)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) Patients
Newly diagnosed HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) patients will undergo blood testing for circulating tumor HPV DNA.
Other: Screening
Blood test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent disease Rate
Time Frame: Up to 5 years
The proportion of patients with recurrence first detected by ctHPV DNA will be calculated as a percentage and 95% confidence intervals (CI) established using binomial exact calculation.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Detection Predictive Properties
Time Frame: Time from first positive ctHPV DNA test to diagnosis of recurrence, assessed up to 5 years
Estimate positive and negative predictive value, sensitivity and specificity of ctHPV DNA for subsequent diagnosis of recurrent HPV-OPC
Time from first positive ctHPV DNA test to diagnosis of recurrence, assessed up to 5 years
Time to diagnosis of recurrence
Time Frame: Time from first positive ctHPV DNA test to confirmed diagnosis of recurrence, assessed up to 5 years
The median (IQR) number of months between the first positive ctHPV DNA test to definitive diagnosis of recurrence will be calculated.
Time from first positive ctHPV DNA test to confirmed diagnosis of recurrence, assessed up to 5 years
Progression-free survival (PFS)
Time Frame: Time from registration to the earlier of progression or death due to any cause, assessed up to 5 years
Calculated using Kaplan Meier method
Time from registration to the earlier of progression or death due to any cause, assessed up to 5 years
Overall survival (OS)
Time Frame: Time from registration to death due to any cause, or censored at date last known alive, assessed up to 5 years
Calculated using Kaplan Meier method
Time from registration to death due to any cause, or censored at date last known alive, assessed up to 5 years
Quality of Life (QOL)
Time Frame: Pre-study, at 3 and 6 months, then at every other visit for the duration of the study up to 5 years
QOL will be evaluated using the by Fear of Recurrence Questionnaire-Short Form (score range 6-40; lower score is lower fear of recurrence) and EQ-5D-5L questionnaire (5 questions with score range 1-5 where higher score is worse; and one question with score range 0-100 where higher is better).
Pre-study, at 3 and 6 months, then at every other visit for the duration of the study up to 5 years
Cost Comparison
Time Frame: Up to 5 years
Projected cost of ctHPV DNA-based compared with standard surveillance
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Eleni M Rettig, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2020

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu Contact the Partners Innovations team at http://www.partners.org/innovation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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