Cell-free Tumor DNA in Head and Neck Cancer Patients

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer; Head and Neck Neoplasms; Nasopharyngeal Carcinoma; Sinonasal Carcinoma; Sinonasal Neoplasm; Head and Neck Squamous Cell Carcinoma; Larynx Neoplasm; Nasopharyngeal Cancer; Hypopharynx Neoplasm; Salivary Gland Carcinoma
• Interventions: Diagnostic Test: Liquid biopsy

• Registration Number: NCT03942380
• Lead Sponsor: Christian von Buchwald

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-21
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cell-free tumor DNA	Liquid biopsy	The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample.
Identifying recurrence	Liquid biopsy	The aim is to identify recurrence through serial monitoring patients with blood samples.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University Hospital of Copenhagen, Rigshospitalet; 🇩🇰 Copenhagen, Region Hovedstaden, Denmark