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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:
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1