SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT01717105
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
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
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
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