Head and Neck NeoplasmsNCT06215612
ctDNA and MRI Parameters in Head and Neck Cancer
A study testing Blood draw, MRI in people with Head and Neck Neoplasms and Carcinoma, Squamous, run by Franziska Eckert.
Trial summary
Patients undergoing primary radiochhemotherapy for locally advanced head and neck squamous cell carcinomas are included in this study. In addition to standard of care treatment patients will undergo addiational blood draws and MR imaging studies. Circulating cell free tumor DNA will be analysed in the blood samples. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Head and Neck Neoplasms, Carcinoma, Squamous
- What is being tested?
- Blood draw, MRI
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Squamous cell carcinoma head and neck
- Planned primary platinum based radiochemotherapy
- ECOG 0-2
Who cannot join
- Palliative therapy intent
- Not MR eligible
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ctDNA and MR Imaging Parameters as Possible Biomarkers in Primary Radiochemotherapy of Head and Neck Squamous Cell Carcinomas
Patients undergoing primary radiochhemotherapy for locally advanced head and neck squamous cell carcinomas are included in this study. In addition to standard of care treatment patients will undergo addiational blood draws and MR imaging studies. Circulating cell free tumor DNA will be analysed in the blood samples. BIological data, imaging data and clinical data (such as patient and tumor characteristics, oncologic outcome, side effects) will be analysed in a biomathematical modelling approach.
- Conditions
- Head and Neck Neoplasms, Carcinoma, Squamous
- Being tested
- Blood draw, MRI
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw, MRIOther
Blood draw, MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with 50% decrease in ctDNA
Measured: 7 weeks after start of radiotherapy
Secondary outcomes (2)
Completion of all planned MR imagings and blood tests
Measured: through study completion, an average of 7 weeks
Decrease of tumor volume
Measured: 7 weeks after start of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2030 (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 NeoplasmsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franziska Eckert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Franziska Eckert, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215612
- Sponsor's protocol ID
- 1452/2023
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA and MR Imaging Parameters as Possible Biomarkers in Primary Radiochemotherapy of Head and Neck Squamous Cell Carcinomas
- ClinicalTrials.gov ID
- NCT06215612
- Acronym / sponsor ID
- 1452/2023
- Conditions
- Head and Neck Neoplasms, Carcinoma, Squamous
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Franziska EckertUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 22 Jan 2024 (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.
Patients undergoing primary radiochhemotherapy for locally advanced head and neck squamous cell carcinomas are included in this study. In addition to standard of care treatment patients will undergo addiational blood draws and MR imaging studies. Circulating cell free tumor DNA will be analysed in the blood samples. BIological data, imaging data and clinical data (such as patient and tumor characteristics, oncologic outcome, side effects) will be analysed in a biomathematical modelling approach.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Squamous cell carcinoma head and neck
- Planned primary platinum based radiochemotherapy
- ECOG 0-2
Key exclusion criteria (2 listed)
- Palliative therapy intent
- Not MR eligible
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 |
|---|---|---|
| Blood draw, MRIBlood draw, MRI | Other | – |
Primary outcome
percentage of patients with 50% decrease in ctDNA
Time frame: 7 weeks after start of radiotherapy
2 secondary outcomes
Completion of all planned MR imagings and blood tests
Time frame: through study completion, an average of 7 weeks
Decrease of tumor volume
Time frame: 7 weeks after start of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw, MRI in people with Head and Neck Neoplasms and Carcinoma, Squamous, run by Franziska Eckert.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franziska Eckert, M.D. (+43-1-40400-26920, franziska.eckert@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with 50% decrease in ctDNA (time frame: 7 weeks after start of radiotherapy). 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 22 Jan 2024.