Head and Neck CancerNCT04260074
Epigenetic Changes in Head and Neck Cancer
An observational study of Head and Neck Cancer and Squamous Cell Carcinoma, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
With this study, the investigators will investigate the epigenetic changes, which may contribute to the development of head and neck squamous cell carcinomas. 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 Cancer, Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Mar 2020to 14 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Cancergroup: Patients referred to The Department of Otolaryngology - Head and Neck surgery Controlgroup: Patients referred to a private clinic for oral and maxillofacial surgery
Who may be able to join
- Written informed consent
- Histologically confirmed oral squamous cell carcinoma
- Written informed consent
- Normal buccal mucosal surface.
- Normal ENT-examination
Who cannot join
- History of cancer
- Uncontrolled comorbidity
- Control group:
- History of cancer
- Uncontrolled comorbidity
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otolaryngology - Head and Neck Surgery
Aalborg, 9000
About this study
Official title: Biomarkers in Head and Neck Cancer - Epigenetic Changes and Hypermethylation of Promoter-regions
With this study, the investigators will investigate the epigenetic changes, which may contribute to the development of head and neck squamous cell carcinomas.
- Conditions
- Head and Neck Cancer, Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Head and Neck Neoplasms
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, 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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Cancer group | 20 consecutive patients with oral squamous cell carcinoma referred to the Department of Otolaryngology - Head and Neck Surgery | |
| Healthy oral mucosa group | 20 controls with normal buccal mucosa upon examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in epigenetic changes
Differences between tumor- and healthy group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start11 Mar 2020
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- 40 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260074
- Sponsor's protocol ID
- N-20190047
- Status last verified
- Jul 2021
- First submitted
- 5 Feb 2020
- Last updated
- 21 Jul 2021
- 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 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Head and Neck Cancer - Epigenetic Changes and Hypermethylation of Promoter-regions
- ClinicalTrials.gov ID
- NCT04260074
- Acronym / sponsor ID
- N-20190047
- Conditions
- Head and Neck Cancer, Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Head and Neck Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 7 Feb 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.
With this study, the investigators will investigate the epigenetic changes, which may contribute to the development of head and neck squamous cell carcinomas.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Cancer group | – | –20 consecutive patients with oral squamous cell carcinoma referred to the Department of Otolaryngology - Head and Neck Surgery |
| Healthy oral mucosa group | – | –20 controls with normal buccal mucosa upon examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cancergroup: Patients referred to The Department of Otolaryngology - Head and Neck surgery Controlgroup: Patients referred to a private clinic for oral and maxillofacial surgery
Key inclusion criteria (5 listed)
- Written informed consent
- Histologically confirmed oral squamous cell carcinoma
- Written informed consent
- Normal buccal mucosal surface.
- Normal ENT-examination
Key exclusion criteria (5 listed)
- History of cancer
- Uncontrolled comorbidity
- History of 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.
Primary outcome
Differences in epigenetic changes
Time frame: 6 months
Differences between tumor- and healthy group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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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.
Michael Gaihede, Professor principal investigator
Department of Otolaryngology - Head and Neck Surgery
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 Cancer and 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences in epigenetic changes (time frame: 6 months). 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 21 Jul 2021.