Cell-free Tumor DNA in Head and Neck Cancer Patients

Christian von Buchwald

Status: Enrolling

Conditions: Oral Neoplasm; Larynx Neoplasm; Sinonasal Cancer; Salivary Gland Carcinoma; Head and Neck Neoplasms; Oral Cancer; Sinonasal Neoplasm; Oral Cavity Cancer; Nasopharynx Neoplasm; Thyroid Neoplasms; Thyroid Cancer; Salivary Gland Cancer; Hypopharynx Carcinoma; Thyroid Carcinoma; Oropharynx Neoplasm; Hypopharynx Cancer; Larynx Carcinoma; Salivary Gland Neoplasms; Hypopharynx Neoplasm; Nasopharyngeal Cancer; Oropharynx Cancer; Nasopharyngeal Carcinoma; Larynx Cancer; Head and Neck Cancer; Oropharynx Carcinoma; Sinonasal Carcinoma; Head and Neck Squamous Cell Carcinoma

Treatments: Diagnostic Test: Liquid biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03942380

1301261

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Cell-free tumor DNA

Other group

Description:

The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample.

Treatment:

Diagnostic Test: Liquid biopsy

Identifying recurrence

Other group

Description:

The aim is to identify recurrence through serial monitoring patients with blood samples.

Treatment:

Diagnostic Test: Liquid biopsy