Observational - The Identification, Validation and Implemention of Prognostic and/or Predictive Biomarkers for Adjuvant Chemotherapy in Early Stage Non-Small Cell Lung Cancer (NSCLC)
I. Validation of the 15-gene prognostic and predictive messenger (m) ribonucleic acid (RNA)
signature on Lung Adjuvant Cisplatin Evaluation (LACE)-Bio formalin-fixed, paraffin-embedded
tissue (FFPE) tumor samples.
II. Exploratory evaluation of the prognostic and predictive values of known potential
oncogenic mutations using LACE-Bio FFPE tumor samples.
III. Exploratory evaluation of the prognostic and predictive values of gene copy variations
using LACE-Bio FFPE tumor samples.
IV. Exploratory identification and evaluation of prognostic and predictive value of novel
genomic aberrations discovered by Next Generation Sequencing on LACE-Bio tumor samples.
Archived RNA and DNA samples are analyzed for gene expression, mutations, and variations by
reverse transcriptase (RT)-polymerase chain reaction (qPCR), mass spectrometry (MassARRAY),
molecular inversion probe assay, and microarray assays. Results are then compared with
patients' clinical outcomes.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Validation of the 15-gene prognostic and predictive mRNA signature by quantitative Nuclease Protection Assay (qNPA) assay and NanoString assay
Post-RNA extraction from tissue
NCIC Clinical Trials Group
United States: Institutional Review Board