SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03562819

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An Observational, Multicentre, Prospective Study to Evaluate Concordance of Detecting EGFR (Epidermal Growth Factor Receptor) Mutation by Circulating Tumour Free DNA Versus Tissues Biopsy in NSCLC (Non-small Cell Lung Cancer).

This is a multicentre, prospective, study of EGFR )Epidermal Growth Factor Receptor) mutation status in advanced NSCLC (Non-small cell lung cancer)patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 268 patients over a period of 6 months.

NCT03562819 NSCLC (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

Description: by tissue and plasma based testing in terms of Overall Concordance, Sensitivity, specificity, Positive predictive value & negative predictive value.

Measure: Determine the level of concordance between EGFR mutation status

Time: 1 Day

Secondary Outcomes

Description: Frequency and percentage of TKI treatment naïve NSCLC patients with T790M mutation will be provided.

Measure: Assess the frequency of T790M mutation among study patients.

Time: 1 Day

Time Perspective: Cross-Sectional

Cohort


There is one SNP

SNPs


1 T790M

by tissue and plasma based testing in terms of Overall Concordance, Sensitivity, specificity, Positive predictive value & negative predictive value.. Assess the frequency of T790M mutation among study patients.. Frequency and percentage of TKI treatment naïve NSCLC patients with T790M mutation will be provided.. Inclusion Criteria: 1. Patients who provide written informed consent 2. Patients aged 18 years and older 3. Newly diagnosed patients with Metastatic (stage IV) NSCLC. --- T790M ---

by tissue and plasma based testing in terms of Overall Concordance, Sensitivity, specificity, Positive predictive value & negative predictive value.. Assess the frequency of T790M mutation among study patients.. Frequency and percentage of TKI treatment naïve NSCLC patients with T790M mutation will be provided.. Inclusion Criteria: 1. Patients who provide written informed consent 2. Patients aged 18 years and older 3. Newly diagnosed patients with Metastatic (stage IV) NSCLC. --- T790M --- --- T790M ---



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