Oropharynx CancerNCT06592716
Can Recurrence of Cancer in the Oropharynx be Detected by Blood Samples?
An observational study of Oropharynx Cancer and Oropharynx Cancer, Metastatic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study investigates if longitudinal analyses of cell-free HPV-DNA in blood samples can be utilized to detect recurrence in patients diagnosed and treated for HPV-positive oropharyngeal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer, Oropharynx Cancer, Metastatic, Oropharynx Cancer, Recurrent
- What is being tested?
- Liquid biopsy
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Apr 2024to 31 Dec 2028
- How long will I take part?
- 2 Years
- 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: Patients with HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma
Who may be able to join
- Patients with newly diagnosed HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma
- Above 18 years of age
- Informed consent
Who cannot join
- The patient does not speak or understand Danish
- patients recieving palliative treatment
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
Copenhagen
About this study
Official title: Specificity and Sensitivity of Circulating HPV-DNA in Patients With Oropharyngeal Squamous Cell Carcinoma
This study investigates if longitudinal analyses of cell-free HPV-DNA in blood samples can be utilized to detect recurrence in patients diagnosed and treated for HPV-positive oropharyngeal squamous cell carcinoma.
- Conditions
- Oropharynx Cancer, Oropharynx Cancer, Metastatic, Oropharynx Cancer, Recurrent, Oropharyngeal Carcinoma, Oropharyngeal Squamous Cell Carcinoma (OPSCC)
- Being tested
- Liquid biopsy
- Keywords
- HPV, HPV-DNA, Liquid biopsy, cell-free HPV-DNA, circulating HPV-DNA, circulating tumor HPV-DNA, ctHPV-DNA
- Medical subject headings
- Oropharyngeal Neoplasms, Neoplasm Metastasis, Recurrence, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid biopsyDiagnostic test
The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for ctHPV-DNA.
| Study group | Role | What they receive |
|---|---|---|
| Identify recurrence | The aim is to identify recurrence through longitudial analyses of circulating tumor HPV-DNA (ctHPV-DNA ) from blood samples. Receives: Diagnostic Test: Liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of HPV ddPCR
Sensitivity and specificity of the ddPCR ctHPV-DNA test compared to clinically or radiologically verified recurrence.
Measured: At enrollment and at 2 months after end treatment, and hereafter every 6 month for a minimum of 2 years, up to 3 years, or at suspicion of recurrence.
Secondary outcomes (5)
Time to recurrence by ctHPV-DNA
Time to recurrence detected by ctHPV-DNA
Measured: From enrollment and for minimum 2 years, up to 3 years, after treatment
Time to recurrence by clinical/radiological examination
Time to recurrence detected by clinical or radiological examination
Measured: From enrollment and for minimum 2 years, up to 3 years, after treatment
PET/CT
Number of PET/CT scans without detectable recurrence
Measured: From enrollment and for minimum 2 years, up to 3 years, after treatment
Cancer fast-track referrals
Number of referrals to Cancer Fast-track clinical investigations (conducted by an ENT specialist) without any detectable recurrences.
Measured: From enrollment and for minimum 2 years, up to 3 years, after treatment
Fear of Recurrence Questionnaire
Quality of Life (QoL) will be evaluated by the Fear of Recurrence Questionnaire (short form) - filled out by patients during follow-up visits
Measured: at 2 months after treatment, and hereafter every 6 months for a minimum of 2 years, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Apr 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Responsible party
- Principal investigator, Christian Grønhøj Larsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian von Buchwald, Professor, MD, DMSci, Study chair, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592716
- Sponsor's protocol ID
- H-23071576
- Other IDs
- p-2023-15163
- Status last verified
- Nov 2025
- First submitted
- 6 Sep 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specificity and Sensitivity of Circulating HPV-DNA in Patients With Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06592716
- Acronym / sponsor ID
- H-23071576
- Conditions
- Oropharynx Cancer, Oropharynx Cancer, Metastatic, Oropharynx Cancer, Recurrent, Oropharyngeal Carcinoma, Oropharyngeal Squamous Cell Carcinoma (OPSCC)
- Keywords
- HPV, HPV-DNA, Liquid biopsy, cell-free HPV-DNA, circulating HPV-DNA, circulating tumor HPV-DNA, ctHPV-DNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
This study investigates if longitudinal analyses of cell-free HPV-DNA in blood samples can be utilized to detect recurrence in patients diagnosed and treated for HPV-positive oropharyngeal squamous cell carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Identify recurrence | – | Diagnostic Test: Liquid biopsyThe aim is to identify recurrence through longitudial analyses of circulating tumor HPV-DNA (ctHPV-DNA ) from blood samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma
Key inclusion criteria (3 listed)
- Patients with newly diagnosed HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma
- Above 18 years of age
- Informed consent
Key exclusion criteria (2 listed)
- The patient does not speak or understand Danish
- patients recieving palliative treatment
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 |
|---|---|---|
| Liquid biopsyThe intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for ctHPV-DNA. | Diagnostic test | Identify recurrence |
Primary outcome
Sensitivity and specificity of HPV ddPCR
Time frame: At enrollment and at 2 months after end treatment, and hereafter every 6 month for a minimum of 2 years, up to 3 years, or at suspicion of recurrence.
Sensitivity and specificity of the ddPCR ctHPV-DNA test compared to clinically or radiologically verified recurrence.
5 secondary outcomes
Time to recurrence by ctHPV-DNA
Time frame: From enrollment and for minimum 2 years, up to 3 years, after treatment
Time to recurrence by clinical/radiological examination
Time frame: From enrollment and for minimum 2 years, up to 3 years, after treatment
PET/CT
Time frame: From enrollment and for minimum 2 years, up to 3 years, after treatment
Cancer fast-track referrals
Time frame: From enrollment and for minimum 2 years, up to 3 years, after treatment
Fear of Recurrence Questionnaire
Time frame: at 2 months after treatment, and hereafter every 6 months for a minimum of 2 years, up to 3 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 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Oropharynx Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
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.
Christian von Buchwald, Professor, MD, DMSci study chair
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet
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 Oropharynx Cancer and Oropharynx Cancer, Metastatic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 2 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 Nov 2025. 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 Denmark. 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?
Sensitivity and specificity of HPV ddPCR (time frame: At enrollment and at 2 months after end treatment, and hereafter every 6 month for a minimum of 2 years, up to 3 years, or at suspicion of recurrence.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2025.