Head and Neck Squamous Cell CarcinomaNCT04567056
Specific Methylation Profiles in HNSCC
An observational study of Head and Neck Squamous Cell Carcinoma, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
In the study, N-20190047, the investigators aim to define specific methylation patterns in a group of patients with head and neck squamous cell carcinomas. With this study the investigators aim to validate these findings in a larger cohort. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Blood sample
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Sep 2020to 1 Jun 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cancer group: Patients referred from the region of Northern Denmark to the Department of Otorhinolaryngology - Head and Neck Surgery with suspicion of, or with already verified Head and neck squamous cell carcinoma. Only patients with verified squamous cell carcinoma after diagnostic work-up will be eligible. Control group: Patients referred from the region of Northern Denmark to the Department of Otorhinolaryngology - Head and Neck Surgery for evaluation or treatment, but without suspected or verified malignancy of the head and neck.
Who may be able to join
- Written informed consent
- Verified head and neck squamous cell carcinoma
- Written informed consent
- Normal ENT-examination
Who cannot join
- Other active cancer
- Uncontrolled comorbidity
- Unable to give informed consent
- Control group:
- Other active cancer
- Uncontrolled comorbidity
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Gaihede, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Otolaryngology - Head and Neck Surgery
Aalborg, 9000
Christian Danstrup, M.D, +45 23800598, csd@rn.dk
About this study
Official title: Validation of Specific Methylation Profiles Ind Head and Neck Cancer - a Cohort Study
In the study, N-20190047, the investigators aim to define specific methylation patterns in a group of patients with head and neck squamous cell carcinomas.
With this study the investigators aim to validate these findings in a larger cohort.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Blood sample
- Keywords
- Head and neck cancer, Squamous Cell carcinoma, Methylation, DNA
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
A separate blood sample will be taken for methylation-analyses
| Study group | Role | What they receive |
|---|---|---|
| Cancer group | Patients with verified head and neck squamous cell carcinomas Receives: Diagnostic Test: Blood sample | |
| Control group | Matched control group without active or earlier cancer and a normal ENT examination. Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
How accurate can the methylation profiles diagnose the head and neck squamous cell carcinoma
Measured: At diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start16 Sep 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Sander Danstrup, Aalborg University Hospital
- Investigators
- Michael Gaihede, Professor, Principal investigator, Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567056
- Sponsor's protocol ID
- N-20190047-2
- Status last verified
- Feb 2025
- First submitted
- 23 Sep 2020
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Specific Methylation Profiles Ind Head and Neck Cancer - a Cohort Study
- ClinicalTrials.gov ID
- NCT04567056
- Acronym / sponsor ID
- N-20190047-2
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and neck cancer, Squamous Cell carcinoma, Methylation, DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 28 Sep 2020 (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 the study, N-20190047, the investigators aim to define specific methylation patterns in a group of patients with head and neck squamous cell carcinomas.
With this study the investigators aim to validate these findings in a larger cohort.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer group | – | Diagnostic Test: Blood samplePatients with verified head and neck squamous cell carcinomas |
| Control group | – | Diagnostic Test: Blood sampleMatched control group without active or earlier cancer and a normal ENT examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer group: Patients referred from the region of Northern Denmark to the Department of Otorhinolaryngology - Head and Neck Surgery with suspicion of, or with already verified Head and neck squamous cell carcinoma. Only patients with verified squamous cell carcinoma after diagnostic work-up will be eligible. Control group: Patients referred from the region of Northern Denmark to the Department of Otorhinolaryngology - Head and Neck Surgery for evaluation or treatment, but without suspected or verified malignancy of the head and neck.
Key inclusion criteria (4 listed)
- Written informed consent
- Verified head and neck squamous cell carcinoma
- Written informed consent
- Normal ENT-examination
Key exclusion criteria (7 listed)
- Other active cancer
- Uncontrolled comorbidity
- Unable to give informed consent
- Other active cancer
- Uncontrolled comorbidity
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 |
|---|---|---|
| Blood sampleA separate blood sample will be taken for methylation-analyses | Diagnostic test | Cancer group, Control group |
Primary outcome
Diagnostic accuracy
Time frame: At diagnosis
How accurate can the methylation profiles diagnose the head and neck squamous cell carcinoma
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 7 Feb 2025.
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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.
Michael Gaihede, Professor contact
Michael Gaihede, Professor principal investigator
Department of Otolaryngology - Head and Neck Surgery, Aalborg University 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 Head and Neck Squamous Cell Carcinoma, run by Aalborg University Hospital 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 Feb 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?
Contact Christian Danstrup, M.D. (+45 23800598, csd@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: At diagnosis). 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 7 Feb 2025; AzTrials last refreshed its copy on 29 Oct 2026.