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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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In the light of a new era in the management of lung cancer this non-interventional study intend to capture all the epidemiological, clinical, pathological, molecular and treatment parameters of non-small cell (NSCLC) and small cell (SCLC) lung cancer patients from a tertiary Oncology Clinic in an Electronic Data Base (EDB).
Investigators intend to build an electronic database which will record the epidemiological, clinical, pathological, molecular data and treatment parameters of lung cancer patients (NSCLC and SCLC) who are referred to a tertiary Oncology Clinic. Documentation will include: a) Patient demographics, co- morbidities, tobacco exposure in pack-years, b) Disease related parameters: method of diagnosis, histological type, disease staging (according to 7th edition of TNM for lung cancer) and metastatic sites if any, c) Molecular status: mutation status for Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Proto-oncogene tyrosine-protein kinase ROS, Hepatocyte Growth Factor Receptor (HGFRor cMET), Human Epidermal Growth Factor Receptor 2 (HER2), proto-oncogene B-Raf, and Programmed-Death Ligand 1 (PD-L1) testing when available, d) Type of treatment (surgery, radiotherapy, chemotherapy, targeted therapies, immune-therapy), and Line of treatment (neo-adjuvant, adjuvant, 1st, 2nd, 3rd, palliation therapy), e) Clinical outcome: Overall Survival (OS), Response Rate (RR), and Progression Free Survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung Cancer patients | All patients with lung cancer that referred to a tertiary Oncology Unit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall Survival (OS) will be recorded for all patients and it is defined as the time in months, from diagnosis till death by any cause. | 12months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Response Rate (RR) is defined as clinical or objective (imaging) response to treatment. Assessments of objective response will be done according to RECIST 1.1.All relevant data (clinical and radiological assessment) will be recorded and reported chronologically and will be correlated with the line and regimen of treatment. | 12 months |
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Inclusion Criteria:
- Since this will be a non-interventional study all adult patients who will be consent for registration of their data to EDB will be enrolled.
Exclusion Criteria:
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All patients with lung cancer that they have been referred to our Unit will be captured to this electronic database
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| Name | Affiliation | Role |
|---|---|---|
| Konstantinos N Syrigos, MD,PhD | Non-Governmental, Non-Profit Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OCEBER | Athens | 11527 | Greece |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Progression Free Survival | Progression Free Survival (PFS) will be captured for all patients. PFS is defined as the time in months, from the start of the treatment till radiological or clinical progression of the disease or death. PFS will be measured for every line of therapy. | 12 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |