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Report for Clinical Trial NCT01717105

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Observational Post-authorization Prospective Study to Characterize the Incidence of Epidermal Growth Factor Receptor (EGFR) Mutation Positive and Advanced Non-small Cell Lung Cancer Patients and Their Clinical Management in Galicia

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.

NCT01717105 Metastatic Non-Small-Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma


Primary Outcomes

Measure: Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia

Time: 10 months (recruitment period)

Secondary Outcomes

Measure: Epidermal growth factor receptor (EGFR) mutational status in tumor tissue (primary tumor or metastatic samples) and plasma samples at screening

Time: 1 day (Screening Visit)

Measure: 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)

Time: 1 day (Screening Visit)

Measure: Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)

Time: 1 day (First study visit)

Measure: Tumor response (only for epidermal growth factor receptor (EGFR) M+ patients)

Time: 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.

Measure: Disease control (only for epidermal growth factor receptor (EGFR) M+ patients)

Time: From inclusion until the end of the study (9 months subsequent to the last patient's inclusion or until lost of follow-up)

Measure: Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients)

Time: 1 day (Progression Visit)

Measure: Progression-free survival and overall survival (only for epidermal growth factor receptor (EGFR) M+ patients)

Time: 1 day (at the end of the study 9 months subsequent to the last patient's inclusion or until lost of follow-up

Measure: 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)

Time: 1 day (Progresion Visit)

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 L858R

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). --- L858R ---



HPO Nodes


HPO: