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Cell-free Tumor DNA in Head and Neck Cancer Patients

Primary Purpose

Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Liquid biopsy
Sponsored by
Christian von Buchwald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital of Copenhagen, RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Cell-free tumor DNA

Identifying recurrence

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Full Information

First Posted
April 15, 2019
Last Updated
September 14, 2021
Sponsor
Christian von Buchwald
Collaborators
Copenhagen University Hospital, Denmark, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
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1. Study Identification

Unique Protocol Identification Number
NCT03942380
Brief Title
Cell-free Tumor DNA in Head and Neck Cancer Patients
Official Title
Cell-free Tumor DNAand HPV-DNA in Blood Samples From Newly Diagnosed Patients With Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christian von Buchwald
Collaborators
Copenhagen University Hospital, Denmark, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cell-free tumor DNA
Arm Type
Other
Arm Description
The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample.
Arm Title
Identifying recurrence
Arm Type
Other
Arm Description
The aim is to identify recurrence through serial monitoring patients with blood samples.
Intervention Type
Diagnostic Test
Intervention Name(s)
Liquid biopsy
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of head and neck cancer detected with a blood sample
Description
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)
Time Frame
0 months
Title
Percentage of head and neck cancer recurrence detected with a blood sample
Description
The primary outcome is to measure the percentage of recurrence in head and neck cancer patients through serial monitoring with liquid biopsies (blood sample)
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Grønhøj, MD, Ph.D
Phone
004526276374
Email
Christian.groenhoej@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Von Buchwald, MD, DMSc
Organizational Affiliation
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Copenhagen, Rigshospitalet
City
Copenhagen
State/Province
Region Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Cell-free Tumor DNA in Head and Neck Cancer Patients

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