Cell-free Tumor DNA in Head and Neck Cancer Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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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

Intervention / Treatment
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* Diagnostic Test: Liquid biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cell-free tumor DNA<br>The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample. | Diagnostic Test: Liquid biopsy<br>* 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<br>|
| Other: Identifying recurrence<br>The aim is to identify recurrence through serial monitoring patients with blood samples. | Diagnostic Test: Liquid biopsy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |