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| ID | Type | Description | Link |
|---|---|---|---|
| NL54778.031.15 | Other Identifier | METC-AVL |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Roche Pharma AG | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
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The investigators hypothesize that an early molecular profiling, that includes both tissue and blood-bases analysis, for all NSCLC patients, including stage I-III, will increase diagnostic efficiency. When molecular profiles are available at an earlier stage of disease, more patients will benefit from personalized therapy once needed. This will result in both a better quality of life and outcome.
In this prospective multicentre trial tumours of all patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing. A minimal molecular profiling is depicted but other targets will be included in due time. The study is divided in two parts. In the first part participating centres will have a run-in period of half a year in which molecular profiling is performed as is currently standard of care. This period will be used to measure the impact of increased awareness on the diagnostic process. During the second part of the study a comprehensive upfront profiling according to local standards will take place for all NSCLC patients. Liquid (blood) biopsies will be included in order to increase the diagnostic yield for those patients where tissue biopsies are not adequate. Patients will be treated according to standard of care, or included in clinical studies where appropriate. Re-biopsies (both tissue and liquid) will be advocated at the time of establishing disease progression/disseminated disease, and personalized therapy will be initiated according to the existing data from the molecular profiling.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid (blood) biopsies and tumor biopsy (optional) | Genetic | Liquid (blood) biopsies: 40 ml (maximal 10 times per patient) Tumor biopsy (optional) |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis | Patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Include the test performance of both techniques in different stage of disease | Test performance of both techniques in different stage of disease | 3 years |
| The percentage of patients with a predefined actionable genetic alteration |
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Inclusion Criteria:
Exclusion Criteria:
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All patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel van den Heuvel, MD | Contact | 0031-20-512 | 9111 | m.vd.heuvel@nki.nl |
| Robert Schouten, MSc | Contact | 0031-20-512 | 9111 | r.schouten@nki.nl |
| Name | Affiliation | Role |
|---|---|---|
| Michel van den Heuvel, MD | Antoni van Leeuwenhoek | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoni van Leeuwenhoek | Recruiting | Amsterdam | North Holland | 1066CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35217576 | Derived | Schuurbiers M, Huang Z, Saelee S, Javey M, de Visser L, van den Broek D, Heuvel MVD, Lovejoy AF, Monkhorst K, Klass D. Biological and technical factors in the assessment of blood-based tumor mutational burden (bTMB) in patients with NSCLC. J Immunother Cancer. 2022 Feb;10(2):e004064. doi: 10.1136/jitc-2021-004064. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D005440 | Fluid Therapy |
| D001800 | Blood Specimen Collection |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
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both tissue and blood samples will be used
Patients with a predefined actionable genetic alteration
| 3 years |
| The costs | The costs | 3 years |
| The influence of the liquid biopsies on the diagnostic yield of tissue molecular and pathological analysis. | Liquid biopsies on the diagnostic yield of tissue molecular | 3 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D003949 | Diagnostic Techniques, Surgical |