Head and Neck CancerNCT03942380
Cell-free Tumor DNA in Head and Neck Cancer Patients
A study testing Liquid biopsy in people with Head and Neck Cancer and Head and Neck Neoplasms, run by Christian von Buchwald at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Liquid biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2017to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years old or older
- Suspicion of head and neck cancer
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, Capital Region, 2100
About this study
Official title: 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.
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Oropharynx Neoplasm, Oropharynx Carcinoma
- Being tested
- Liquid biopsy
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms, Mouth Neoplasms, Laryngeal Neoplasms, Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid biopsyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Liquid biopsy |
| Identifying recurrence | Other | The aim is to identify recurrence through serial monitoring patients with blood samples. Receives: Diagnostic Test: Liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Feb 2017
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian von Buchwald
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
- Responsible party
- Sponsor-investigator, Christian von Buchwald, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian Von Buchwald, MD, DMSc, Principal investigator, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942380
- Sponsor's protocol ID
- 1301261
- Status last verified
- Sep 2021
- First submitted
- 15 Apr 2019
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell-free Tumor DNAand HPV-DNA in Blood Samples From Newly Diagnosed Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03942380
- Acronym / sponsor ID
- 1301261
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Oropharynx Neoplasm, Oropharynx Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Christian von BuchwaldUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell-free tumor DNA | Other | Diagnostic Test: Liquid biopsyThe aim is to differentiate between patients with head and neck cancer from those without based on a blood sample. |
| Identifying recurrence | Other | Diagnostic Test: Liquid biopsyThe aim is to identify recurrence through serial monitoring patients with blood samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years old or older
- Suspicion of head and neck cancer
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid biopsyThe 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 | Diagnostic test | Cell-free tumor DNA, Identifying recurrence |
Primary outcome
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Von Buchwald, MD, DMSc principal investigator
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid biopsy in people with Head and Neck Cancer and Head and Neck Neoplasms, run by Christian von Buchwald at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Grønhøj, MD, Ph.D (004526276374, Christian.groenhoej@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of head and neck cancer detected with a blood sample (time frame: 0 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.