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| ID | Type | Description | Link |
|---|---|---|---|
| GGC-CPN-2010-01 | Other Identifier | AEMPS |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Dynamic Solutions | INDUSTRY |
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The present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metastatic non-small cell lung cancer | Only epidermal growth factor receptor (EGFR) M+ patients will be eligible for the study assessments |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia | 10 months (recruitment period) |
| Measure | Description | Time Frame |
|---|---|---|
| Epidermal growth factor receptor (EGFR) mutational status in tumor tissue (primary tumor or metastatic samples) and plasma samples at screening | 1 day (Screening Visit) | |
| Type of epidermal growth factor receptor (EGFR) mutations: deletion in exon 19, point mutation at codon 858 (L858R) or other (only for EGFR M+ patients) |
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Inclusion Criteria:
Inclusion Criteria for patients´ screening:
Patients must fulfill the inclusion criteria previously mentioned and the following one in order to be enrolled in the study (visit 1) for the follow-up until progression or until 9 months from the beginning of treatment have elapsed:
Inclusion Criteria for patients´ follow-up
Exclusion Criteria:
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Outpatient consultation in oncology
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Vázquez Estévez, Doctor | Grupo Gallego de Cáncer de Pulmón (GGCP) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Oncologico de Galicia | A Coruña | A Coruña | 15009 | Spain | ||
| Complexo Hospitalario Arquitecto Marcide |
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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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Tumor tissue Plasma samples
| 1 day (Screening Visit) |
| Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients) | 1 day (First study visit) |
| Tumor response (only for epidermal growth factor receptor (EGFR) M+ patients) | From inclusion until disease progression, death or until 9 months from the inclusion of the last patient in the study have elapsed, whichever is earlier. |
| Disease control (only for epidermal growth factor receptor (EGFR) M+ patients) | From inclusion until the end of the study (9 months subsequent to the last patient's inclusion or until lost of follow-up) |
| Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients) | 1 day (Progression Visit) |
| Progression-free survival and overall survival (only for epidermal growth factor receptor (EGFR) M+ patients) | 1 day (at the end of the study 9 months subsequent to the last patient's inclusion or until lost of follow-up |
| Epidermal growth factor receptor (EGFR) mutational status at disease progression in tumor tissue (primary tumor or metastatic samples) and plasma samples (only for EGFR M+ patients) | 1 day (Progresion Visit) |
| Ferrol |
| A Coruña |
| 15405 |
| Spain |
| Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | A Coruña | 15706 | Spain |
| Lucus Augusti Hospital | Lugo | Lugo | 27004 | Spain |
| Complejo Hospitalario de Ourense | Ourense | Orense | 32005 | Spain |
| Complexo Hospitalario de Pontevedra | Pontevedra | Pontevedra | 36071 | Spain |
| Hospital do Meixoeiro | Vigo | Pontevedra | 36200 | Spain |
| Hospital Xeral-Cíes | Vigo | Pontevedra | 36204 | Spain |
| Hospital Povisa | Vigo | Pontevedra | 36211 | Spain |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |