Cell-free Tumor DNA in Head and Neck Cancer Patients

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Brief Title

Cell-free Tumor DNA in Head and Neck Cancer Patients

Official Title

Cell-free Tumor DNAand HPV-DNA in Blood Samples From Newly Diagnosed Patients With Head and Neck Cancer

Brief Summary

      This study investigates if head and neck squamous cell carcinoma can be tracked with
      cell-free tumor DNA, RNA or HPV-DNA, in blood samples from patients referred with suspicion
      of cancer, and if it can be used in detecting recurrence in patients already diagnosed and
      treated for head and neck squamous cell carcinoma.

Study Type

Interventional

Primary Outcome

Percentage of head and neck cancer detected with a blood sample

Condition

Head and Neck Cancer

Intervention

Liquid biopsy

Study Arms / Comparison Groups

 Cell-free tumor DNA
Description:  The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

500

Start Date

February 1, 2017

Completion Date

February 1, 2025

Primary Completion Date

February 1, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Patients 18 years old or older

          -  Suspicion of head and neck cancer

        Exclusion Criteria:

          -  Diagnosed with cancer within the last 3 years ( apart from basal cell carcinoma)

          -  Diagnosed with an inflammatory or haematological disease after the age of 18

          -  Received chemotherapy or immunosuppressive treatment within the last 3 years

          -  Underwent a FNA ( fine-needle aspiration biopsy) or a biopsy from the head and neck
             region within 1 week.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christian Von Buchwald, MD, DMSc, 004526276374, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT03942380

Organization ID

1301261

Responsible Party

Sponsor-Investigator

Study Sponsor

Christian von Buchwald

Collaborators

 Copenhagen University Hospital, Denmark

Study Sponsor

Christian Von Buchwald, MD, DMSc, Principal Investigator, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

Verification Date

September 2021