SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01717105

Developed by Shray Alag, 2019.
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 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1