Cell-free Tumor DNA in Head and Neck Cancer Patients

September 14, 2021 updated by: Christian von Buchwald

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Region Hovedstaden
      • Copenhagen, Region Hovedstaden, Denmark, 2100
        • Recruiting
        • University Hospital of Copenhagen, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of head and neck cancer detected with a blood sample
Time Frame: 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)
0 months
Percentage of head and neck cancer recurrence detected with a blood sample
Time Frame: 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)
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christian von Buchwald

Collaborators

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

Investigators

  • Principal Investigator: Christian Von Buchwald, MD, DMSc, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1301261

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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