Specific Methylation Profiles in HNSCC
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christian Danstrup, M.D.
- Phone Number: +45 23800598
- Email: csd@rn.dk
Study Contact Backup
- Name: Michael Gaihede, Professor
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
Cancer group:
Inclusion Criteria:
- Written informed consent
- Verified head and neck squamous cell carcinoma
Exclusion Criteria:
- Other active cancer
- Uncontrolled comorbidity
- Unable to give informed consent
Control group:
Inclusion Criteria:
- Written informed consent
- Normal ENT-examination
Exclusion Criteria:
- Other active cancer
- Uncontrolled comorbidity
- Unable to give informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cancer group
Patients with verified head and neck squamous cell carcinomas
|
A separate blood sample will be taken for methylation-analyses
|
|
Control group
Matched control group without active or earlier cancer and a normal ENT examination.
|
A separate blood sample will be taken for methylation-analyses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy
Time Frame: At diagnosis
|
How accurate can the methylation profiles diagnose the head and neck squamous cell carcinoma
|
At diagnosis
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Gaihede, Professor, Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-20190047-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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