Epigenetic Changes in Head and Neck Cancer

July 20, 2021 updated by: Christian Sander Danstrup, Aalborg University Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Department of Otolaryngology - Head and Neck Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

Cancer group:

Inclusion Criteria :

  • Written informed consent
  • Histologically confirmed oral squamous cell carcinoma

Exclusion Criteria:

  • History of cancer
  • Uncontrolled comorbidity

Control group:

Inclusion Criteria :

  • Written informed consent
  • Normal buccal mucosal surface.
  • Normal ENT-examination

Exclusion Criteria:

  • History of cancer
  • Uncontrolled comorbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in epigenetic changes
Time Frame: 6 months
Differences between tumor- and healthy group
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Investigators

  • Principal Investigator: Michael Gaihede, Professor, Department of Otolaryngology - Head and Neck Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2020

Primary Completion (Actual)

July 14, 2021

Study Completion (Actual)

July 14, 2021

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20190047

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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