Post-treatment Surveillance in HPV+ Oropharyngeal SCC
June 16, 2026 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
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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-
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.
|
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
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.
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 18, 2026
Last Update Submitted That Met QC Criteria
June 16, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Disease Attributes
- Infections
- Virus Diseases
- Neoplasms by Histologic Type
- Head and Neck Neoplasms
- Neoplasms, Glandular and Epithelial
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- DNA Virus Infections
- Carcinoma
- Tumor Virus Infections
- Carcinoma, Squamous Cell
- Pathological Conditions, Signs and Symptoms
- Squamous Cell Carcinoma of Head and Neck
- Papillomavirus Infections
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Diagnostic Techniques and Procedures
- Diagnosis
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Health Services
- Health Care Facilities Workforce and Services
- Preventive Health Services
- Diagnostic Services
- Health Surveys
- Surveys and Questionnaires
- Public Health Practice
- Mass Screening
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.