Cell-free Tumor DNA in Head and Neck Cancer Patients

NCT03942380 | Unknown

• 1 other identifier: 1301261
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cell-free tumor DNA

OTHER

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

Diagnostic Test: Liquid biopsy

Identifying recurrence

OTHER

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

Diagnostic Test: Liquid biopsy

Interventions

Liquid biopsy DIAGNOSTIC_TEST

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

Cell-free tumor DNA; Identifying recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years old or older
• Suspicion of head and neck cancer

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian von Buchwald: lead
• Copenhagen University Hospital, Denmark: collaborator
• Department of Otorhinolaryngology, Head and Neck Surgery and Audiology: collaborator

Study Sites (1)

University Hospital of Copenhagen, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms; Mouth Neoplasms; Laryngeal Neoplasms; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Hypopharyngeal Neoplasms; Thyroid Neoplasms; Salivary Gland Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Nasopharyngeal Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Christian Von Buchwald, MD, DMSc

  Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Grønhøj, MD, Ph.D

CONTACT

004526276374; Christian.groenhoej@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 8, 2019
• Study Start: February 1, 2017
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

DK (1)