Cell-free Tumor DNA in Head and Neck Cancer Patients

Sponsor

Christian von Buchwald (Other)

Overall Status

Recruiting

CT.gov ID

NCT03942380

Collaborator

Copenhagen University Hospital, Denmark (Other), Department of Otorhinolaryngology, Head and Neck Surgery and Audiology (Other)

500

Enrollment

Location

Arms

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Diagnostic Test: Liquid biopsy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 1, 2017

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Cell-free tumor DNA The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample.	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
Other: Identifying recurrence The aim is to identify recurrence through serial monitoring patients with blood samples.	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

Arm

Intervention/Treatment

Other: Cell-free tumor DNA

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

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

Other: Identifying recurrence

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

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

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.