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Report for Clinical Trial NCT03562819

Developed by Shray Alag, 2020.
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: