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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595074
|National Cancer Institute of Canada Clinical Trials Group|
|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|