Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Hypopharynx Cancer, Hypopharynx Carcinoma, Hypopharynx Neoplasm, Larynx Cancer, Larynx Carcinoma, Larynx Neoplasm, Nasopharyngeal Cancer, Nasopharyngeal Carcinoma, Nasopharynx Neoplasm, Oral Cancer, Oral Cavity Cancer, Oral Neoplasm, Oropharynx Cancer, Oropharynx Carcinoma, Oropharynx Neoplasm, Salivary Gland Cancer, Salivary Gland Carcinoma, Salivary Gland Neoplasms, Sinonasal Cancer, Sinonasal Carcinoma, Sinonasal Neoplasm, Thyroid Cancer, Thyroid Carcinoma, Thyroid Neoplasms
Conditions
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.
Interventions
DIAGNOSTIC_TESTLiquid 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
Sponsors
Copenhagen University Hospital, Denmark
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
Christian von Buchwald
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of head and neck cancer detected with a blood sample | 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) |
| Percentage of head and neck cancer recurrence detected with a blood sample | 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) |
Countries
Denmark
Contacts
Primary ContactChristian Grønhøj, MD, Ph.D
Outcome results
None listed