HPVNCT04965792
Post-treatment Surveillance in HPV+ Oropharyngeal SCC
An observational study of HPV and Oropharyngeal Squamous Cell Carcinoma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV, Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Screening
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with HPV-positive oropharynx cancer undergoing curative-intent treatment.
Who may be able to join
- 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
Who cannot join
- Distant metastatic disease (M1, AJCC 8th edition)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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.
- Conditions
- HPV, Oropharyngeal Squamous Cell Carcinoma
- Being tested
- Screening
- Keywords
- HPV, Oropharyngeal Squamous Cell Carcinoma, HPV + Oropharyngeal Squamous Cell Carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Blood test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Secondary outcomes (6)
Recurrence Detection Predictive Properties
Estimate positive and negative predictive value, sensitivity and specificity of ctHPV DNA for subsequent diagnosis of recurrent HPV-OPC
Measured: Time from first positive ctHPV DNA test to diagnosis of recurrence, assessed up to 5 years
Time to diagnosis of recurrence
The median (IQR) number of months between the first positive ctHPV DNA test to definitive diagnosis of recurrence will be calculated.
Measured: Time from first positive ctHPV DNA test to confirmed diagnosis of recurrence, assessed up to 5 years
Progression-free survival (PFS)
Calculated using Kaplan Meier method
Measured: Time from registration to the earlier of progression or death due to any cause, assessed up to 5 years
Overall survival (OS)
Calculated using Kaplan Meier method
Measured: 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)
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).
Measured: Pre-study, at 3 and 6 months, then at every other visit for the duration of the study up to 5 years
Cost Comparison
Projected cost of ctHPV DNA-based compared with standard surveillance
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start19 Nov 2020
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleni Marie Rettig, MD, Dana-Farber Cancer Institute
- Investigators
- Eleni M Rettig, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965792
- Sponsor's protocol ID
- 20-340
- Status last verified
- Jun 2026
- First submitted
- 19 Apr 2021
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39715483
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating HPV DNA for Post-treatment Surveillance in HPV-positive Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04965792
- Acronym / sponsor ID
- 20-340
- Conditions
- HPV, Oropharyngeal Squamous Cell Carcinoma
- Keywords
- HPV, Oropharyngeal Squamous Cell Carcinoma, HPV + Oropharyngeal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) Patients | – | Other: ScreeningNewly diagnosed HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) patients will undergo blood testing for circulating tumor HPV DNA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with HPV-positive oropharynx cancer undergoing curative-intent treatment.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Distant metastatic disease (M1, AJCC 8th edition)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScreeningBlood test | Other | HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) Patients |
Primary outcome
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.
6 secondary outcomes
Recurrence Detection Predictive Properties
Time frame: 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
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
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
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
Cost Comparison
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 39715483Rettig 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleni M Rettig, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV and Oropharyngeal Squamous Cell Carcinoma, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent disease Rate (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.