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RecruitingNCT04567056Updated Feb 7, 2025

Specific Methylation Profiles in HNSCC

An observational study in Head and Neck Squamous Cell Carcinoma, sponsored by Aalborg University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.

Sponsored by Aalborg University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Sep 2020; still recruiting 6 years 1 month later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Head and Neck Squamous Cell Carcinoma

Keywords

  • Head and neck cancer
  • Squamous Cell carcinoma
  • Methylation
  • DNA
03

In context

Squamous Cell Carcinoma of Head and Neck

1,711 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 544 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 179 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Eligibility criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cancer group

    Patients with verified head and neck squamous cell carcinomas

    Diagnostic Test: Blood sample

  • Control group

    Matched control group without active or earlier cancer and a normal ENT examination.

    Diagnostic Test: Blood sample

Interventions

  • Diagnostic testBlood sample

    A separate blood sample will be taken for methylation-analyses

06

What researchers measure

Primary outcomes

  1. Diagnostic accuracy

    How accurate can the methylation profiles diagnose the head and neck squamous cell carcinoma

    Time frame: At diagnosis

07

Study locations

1 of 1 sites recruiting
  • Department of Otolaryngology - Head and Neck Surgery
    Aalborg, 9000, Denmark
    • Christian Danstrup, M.D · Contact · csd@rn.dk · +45 23800598
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04567056
Responsible party
Christian Sander Danstrup (Associate Professor, M.D., Aalborg University Hospital) — Principal investigator
First posted
Sep 28, 2020
Start date
Sep 16, 2020
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Feb 7, 2025

Study contacts

Christian Danstrup, M.D.
Contact
csd@rn.dk
+45 23800598
Michael Gaihede, Professor
Contact
Michael Gaihede, Professor
principal investigator · Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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