NCT04567056

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

5.3 years

First QC Date

September 23, 2020

Last Update Submit

February 5, 2025

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and neck cancerSquamous Cell carcinomaMethylationDNA

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

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

    At diagnosis

Study Arms (2)

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

Blood sampleDIAGNOSTIC_TEST

A separate blood sample will be taken for methylation-analyses

Cancer groupControl group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Written informed consent
  • Verified head and neck squamous cell carcinoma

You may not qualify if:

  • Other active cancer
  • Uncontrolled comorbidity
  • Unable to give informed consent
  • Control group:
  • Written informed consent
  • Normal ENT-examination
  • Other active cancer
  • Uncontrolled comorbidity
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology - Head and Neck Surgery

Aalborg, 9000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck NeoplasmsCarcinoma, Squamous Cell

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Michael Gaihede, Professor

    Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Danstrup, M.D.

CONTACT

+45 23800598csd@rn.dk

Michael Gaihede, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D.

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 28, 2020

Study Start

September 16, 2020

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

February 7, 2025

Record last verified: 2025-02

Locations

DK(1)