Post-treatment Surveillance in HPV+ Oropharyngeal SCC
Circulating HPV DNA for Post-treatment Surveillance in HPV-positive Oropharyngeal Squamous Cell Carcinoma
1 other identifier
observational
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 19, 2020
CompletedFirst Submitted
Initial submission to the registry
April 19, 2021
CompletedFirst Posted
Study publicly available on registry
July 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
June 17, 2025
June 1, 2025
6 years
April 19, 2021
June 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrent disease Rate
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 Outcomes (6)
Recurrence Detection Predictive Properties
Time from first positive ctHPV DNA test to diagnosis of recurrence, assessed up to 5 years
Time to diagnosis of recurrence
Time from first positive ctHPV DNA test to confirmed diagnosis of recurrence, assessed up to 5 years
Progression-free survival (PFS)
Time from registration to the earlier of progression or death due to any cause, assessed up to 5 years
Overall survival (OS)
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)
Pre-study, at 3 and 6 months, then at every other visit for the duration of the study up to 5 years
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
Eligibility Criteria
Individuals with HPV-positive oropharynx cancer undergoing curative-intent treatment.
You may qualify if:
- 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
You may not qualify if:
- Distant metastatic disease (M1, AJCC 8th edition)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Related Publications (1)
Rettig EM, Schoenfeld JD, Miller J, Sargent B, Carey E, Margalit DN, Sehgal K, Sethi RKV, Uppaluri R, Tishler RB, Goguen LA, Annino DJ, Sim ES, Jo VY, Wong KS, Guenette JP, Haddad RI, Hanna GJ. A Prospective Trial of Biomarker-Guided Surveillance for HPV-Positive Oropharynx Cancer Using Plasma Tumor Tissue-Modified Viral HPV DNA. Clin Cancer Res. 2025 May 1;31(9):1605-1614. doi: 10.1158/1078-0432.CCR-24-3053.
PMID: 39715483BACKGROUND
Biospecimen
Blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eleni M Rettig, MD
Brigham and Women's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 19, 2021
First Posted
July 16, 2021
Study Start
November 19, 2020
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2027
Last Updated
June 17, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- 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
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.