Observational - The Identification, Validation and Implemention of Prognostic and/or Predictive Biomarkers for Adjuvant Chemotherapy in Early Stage Non-Small Cell Lung Cancer (NSCLC)
18 Years
N/A
Both
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
Trial Information
Observational - The Identification, Validation and Implemention of Prognostic and/or Predictive Biomarkers for Adjuvant Chemotherapy in Early Stage Non-Small Cell Lung Cancer (NSCLC)
OBJECTIVES:
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.
OUTLINE:
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.
Inclusion Criteria:
- Samples from patients treated in 4 adjuvant chemotherapy (ACT) for early-stage
non-small cell lung cancer (NSCLC) pivotal trials:
- International Adjuvant Lung Cancer Trail (IALT)
- Cancer and Leukemia Group B (CALGB)-9633
- CAN-NCIC-BR10
- Adjuvant Navelbine International Trialist Association (ANITA)
- Not specified
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Validation of the 15-gene prognostic and predictive mRNA signature by quantitative Nuclease Protection Assay (qNPA) assay and NanoString assay
Outcome Time Frame:
Post-RNA extraction from tissue
Safety Issue:
No
Principal Investigator
Lesley Seymour
Investigator Role:
Principal Investigator
Investigator Affiliation:
NCIC Clinical Trials Group
Authority:
United States: Institutional Review Board
Study ID:
NCI-2012-01965
NCT ID:
NCT01595074
Start Date:
May 2012
Completion Date:
Related Keywords:
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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