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NCT03942380 Clinical Trial

Cell-free Tumor DNA in Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03942380
Other study ID # 1301261
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date February 1, 2025

Study information
Verified date September 2021
Source Rigshospitalet, Denmark
Contact Christian Grønhøj, MD, Ph.D
Phone 004526276374
Email Christian.groenhoej@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Head and Neck Squamous Cell Carcinoma
  • Hypopharynx Cancer
  • Laryngeal Diseases
  • Laryngeal Neoplasms
  • Larynx Cancer
  • Larynx Carcinoma
  • Mouth Neoplasms
  • Nasopharyngeal Cancer
  • Nasopharyngeal Carcinoma
  • Nasopharyngeal Neoplasms
  • Neoplasms
  • Oral Cancer
  • Oral Cavity Cancer
  • Oral Neoplasm
  • Oropharyngeal Neoplasms
  • Oropharynx Cancer
  • Salivary Gland Cancer
  • Salivary Gland Carcinoma
  • Salivary Gland Neoplasms
  • Sinonasal Cancer
  • Sinonasal Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Thyroid Cancer
  • Thyroid Carcinoma
  • Thyroid Diseases
  • Thyroid Neoplasms

Intervention

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

Locations
Country Name City State
Denmark University Hospital of Copenhagen, Rigshospitalet Copenhagen Region Hovedstaden

Sponsors (3)
Lead Sponsor Collaborator
Christian von Buchwald Copenhagen University Hospital, Denmark, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of head and neck cancer detected with a blood sample 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) 0 months
Primary Percentage of head and neck cancer recurrence detected with a blood sample The primary outcome is to measure the percentage of recurrence in head and neck cancer patients through serial monitoring with liquid biopsies (blood sample) 36 months
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