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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02921854 |
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Date of registration:
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28/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Detection of Circulating Biomarkers of Immunogenic Cell Death
ICD |
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Scientific title:
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Detection of Circulating Biomarkers of Immunogenic Cell Death After Radiotherapy and Chemotherapy: An Exploratory Study |
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Date of first enrolment:
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April 4, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02921854 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Netherlands
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Contacts
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Name:
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Dirk De Ruysscher, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maastro Clinic, The Netherlands |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female, aged 18 years or above.
- Diagnosed with non-small cell lung cancer
- Scheduled to receive one of the following two therapeutic strategies:
- Concurrent cisplatin-doublet chemotherapy and radiotherapy (minimal dose of 60 Gy
in fractionated non-ablative doses) in patients with stage III NSCLC
- SBRT for stage I NSCLC: 54Gy in 3 fractions, 48 Gy in 4 fractions or 60 Gy in 8
or 5 fractions
- Is able and willing to comply with all trial requirements.
Exclusion Criteria:
1. Chronic use of corticosteroids, except when used as anti-emetics for chemotherapy or
inhalers
2. NSAIDs taken until 5 days before radiotherapy or during radiation (low dose Aspirin at
a maximum of 160 mg/day, is allowed)
3. Active auto-immune diseases
4. Immunosuppressive medication
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non Small Cell Lung Cancer
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Intervention(s)
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Other: Blood withdrawal
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Primary Outcome(s)
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Changes of lipid profile for plasma / plasma, linked to ICD
[Time Frame: 5 weeks (during radiotherapy)]
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Changes of relative protein expression / derived exosomes, linked to ICD
[Time Frame: 5 weeks (during radiotherapy)]
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Secondary Outcome(s)
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Changes of relative protein expression, linked to Th1/Th2 subsets
[Time Frame: 5 weeks (during radiotherapy)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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