Biomarkers in Predicting Treatment Response in Samples From Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01595074|
Recruitment Status : Not yet recruiting
First Posted : May 9, 2012
Last Update Posted : September 20, 2013
|Condition or disease||Intervention/treatment|
|Stage IA Non-small Cell Lung Cancer Stage IB Non-small Cell Lung Cancer Stage IIA Non-small Cell Lung Cancer Stage IIB Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer||Other: medical chart review Other: laboratory biomarker analysis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||950 participants|
|Official Title:||The Identification, Validation and Implemention of Prognostic and/or Predictive Biomarkers for Adjuvant Chemotherapy in Early Stage Non-Small Cell Lung Cancer (NSCLC)|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||January 2100|
Ancillary-Correlative (laboratory biomarkre analysis)
Archived RNA and DNA samples are analyzed for gene expression, mutations, and variations by RT-qPCR, MassARRAY, molecular inversion probe assay, and microarray assays. Results are then compared with patients' clinical outcomes.
Other: medical chart review
Other Name: chart review
Other: laboratory biomarker analysis
- Validation of the 15-gene prognostic and predictive mRNA signature by quantitative Nuclease Protection Assay (qNPA) assay and NanoString assay [ Time Frame: Post-RNA extraction from tissue ]
- Prognostic and predictive value of known potential oncogenic mutations and gene copy variations of novel genomic aberrations on disease free survival (DFS) and overall survival (OS) [ Time Frame: Post-RNA extraction from tissue ]Survival curves will be estimated using Kaplan-Meier methods and compared with the log-rank test. The hypothesis of constant risk ratio over time in the Cox proportional hazards (PH) model will be tested by introducing a time-dependent interaction with the marker or using Schoenfeld's residuals.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595074
|National Cancer Institute of Canada Clinical Trials Group||Not yet recruiting|
|Kingston, Ontario, Canada, K7L 3N6|
|Contact: Lesley K. Seymour 613-533-6430 firstname.lastname@example.org|
|Principal Investigator: Lesley K. Seymour|
|Principal Investigator:||Lesley Seymour||Canadian Cancer Trials Group|