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Epigenetic Changes in Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04260074
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Christian Sander Danstrup, Aalborg University Hospital

Brief Summary:
With this study, the investigators will investigate the epigenetic changes, which may contribute to the development of head and neck squamous cell carcinomas.

Condition or disease
Head and Neck Cancer Squamous Cell Carcinoma Head and Neck Squamous Cell Carcinoma Head and Neck Neoplasms

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarkers in Head and Neck Cancer - Epigenetic Changes and Hypermethylation of Promoter-regions
Estimated Study Start Date : February 10, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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 consecutive patients referred to a private clinic for oral and maxillofacial surgery with normal buccal mucosa upon examination.



Primary Outcome Measures :
  1. Differences in epigenetic changes [ Time Frame: 6 months ]
    Differences between tumor- and healthy group


Biospecimen Retention:   Samples With DNA
Biopsies from tumour and healthy buccal mucosa. Blood samples from both case and control group.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260074


Contacts
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Contact: Christian Danstrup, M.D +45 23800598 csd@rn.dk

Locations
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Denmark
Department of Otolaryngology - Head and Neck Surgery Recruiting
Aalborg, Denmark, 9000
Contact: Christian Danstrup, M.D    +45 23800598    csd@rn.dk   
Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Principal Investigator: Michael Gaihede, Professor Department of Otolaryngology - Head and Neck Surgery

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Responsible Party: Christian Sander Danstrup, MD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04260074    
Other Study ID Numbers: N-20190047
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site