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出境医 / 临床实验 / Cell-free Tumor DNA in Head and Neck Cancer Patients
Cell-free Tumor DNA in Head and Neck Cancer Patients
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Cancer Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma | Diagnostic Test: Liquid biopsy | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Diagnostic |
| Official Title: | Cell-free Tumor DNAand HPV-DNA in Blood Samples From Newly Diagnosed Patients With Head and Neck Cancer |
| Actual Study Start Date : | February 1, 2017 |
| Estimated Primary Completion Date : | February 1, 2025 |
| Estimated Study Completion Date : | February 1, 2025 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Cell-free tumor DNA
The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample.
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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
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Identifying recurrence
The aim is to identify recurrence through serial monitoring patients with blood samples.
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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
|
Outcome Measures
Primary Outcome Measures :
- 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)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Contacts
| Contact: Christian Grønhøj, MD, Ph.D | 004526276374 | Christian.groenhoej@regionh.dk |
Locations
| Denmark | |
| University Hospital of Copenhagen, Rigshospitalet | Recruiting |
| Copenhagen, Region Hovedstaden, Denmark, 2100 | |
Sponsors and Collaborators
Christian von Buchwald
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 |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 15, 2019 | ||||
| First Posted Date ICMJE | May 8, 2019 | ||||
| Last Update Posted Date | March 11, 2021 | ||||
| Actual Study Start Date ICMJE | February 1, 2017 | ||||
| Estimated Primary Completion Date | February 1, 2025 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cell-free Tumor DNA in Head and Neck Cancer Patients | ||||
| Official Title ICMJE | Cell-free Tumor DNAand HPV-DNA in Blood Samples From Newly Diagnosed Patients With Head and Neck Cancer | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: Single (Participant) Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | 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
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
500 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | February 1, 2025 | ||||
| Estimated Primary Completion Date | February 1, 2025 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Denmark | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03942380 | ||||
| Other Study ID Numbers ICMJE | 1301261 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Christian von Buchwald, Rigshospitalet, Denmark | ||||
| Study Sponsor ICMJE | Christian von Buchwald | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Rigshospitalet, Denmark | ||||
| Verification Date | March 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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