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Cell-free Tumor DNA in Head and Neck Cancer Patients

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ClinicalTrials.gov Identifier: NCT03942380
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : September 21, 2021
Sponsor:
Collaborators:
Copenhagen University Hospital, Denmark
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
Information provided by (Responsible Party):
Christian von Buchwald, Rigshospitalet, Denmark

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Oropharynx Cancer Oropharynx Neoplasm Oropharynx Carcinoma Oral Cavity Cancer Oral Cancer Oral Neoplasm Larynx Cancer Larynx Carcinoma Larynx Neoplasm Nasopharyngeal Carcinoma Nasopharyngeal Cancer Nasopharynx Neoplasm Hypopharynx Cancer Hypopharynx Neoplasm Hypopharynx Carcinoma Sinonasal Carcinoma Thyroid Carcinoma Thyroid Cancer Thyroid Neoplasms Salivary Gland Cancer Salivary Gland Neoplasms Salivary Gland Carcinoma Sinonasal Cancer Sinonasal Neoplasm Diagnostic Test: Liquid biopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Cell-free Tumor DNAand HPV-DNA in Blood Samples From Newly Diagnosed Patients With Head and Neck Cancer
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Cell-free tumor DNA
The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample.
 Diagnostic Test: Liquid biopsy
The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for cell free DNA, RNA and HPV-DNA
Identifying recurrence
The aim is to identify recurrence through serial monitoring patients with blood samples.
 Diagnostic Test: Liquid biopsy
The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for cell free DNA, RNA and HPV-DNA


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of head and neck cancer detected with a blood sample [ Time Frame: 0 months ]
    The primary outcome is to measure the percentage of head and neck squamous cell carcinomas that can be detected using a liquid biopsy (blood sample)

  2. Percentage of head and neck cancer recurrence detected with a blood sample [ Time Frame: 36 months ]
    The primary outcome is to measure the percentage of recurrence in head and neck cancer patients through serial monitoring with liquid biopsies (blood sample)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT03942380


Contacts
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Contact: Christian Grønhøj, MD, Ph.D 004526276374 Christian.groenhoej@regionh.dk

Locations
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Denmark
University Hospital of Copenhagen, Rigshospitalet Recruiting
Copenhagen, Region Hovedstaden, Denmark, 2100
Sponsors and Collaborators
Christian von Buchwald
Copenhagen University Hospital, Denmark
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
Investigators
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Principal Investigator: Christian Von Buchwald, MD, DMSc Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
More Information
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Responsible Party: Christian von Buchwald, Clinical Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03942380    
Other Study ID Numbers: 1301261
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021

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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
Neoplasms
Head and Neck Neoplasms
Thyroid Neoplasms
Nasopharyngeal Carcinoma
Squamous Cell Carcinoma of Head and Neck
Salivary Gland Neoplasms
Mouth Neoplasms
Nasopharyngeal Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms
Laryngeal Diseases
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Carcinoma, Squamous Cell
Neoplasms by Site
Endocrine System Diseases
Endocrine Gland Neoplasms
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Mouth Diseases
Salivary Gland Diseases
Respiratory Tract Neoplasms