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)
Brief Title
Biomarkers in Predicting Treatment Response in Samples From Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy
Protocol ID
NCT01595074
Lead Sponsor
National Cancer Institute (NCI)
Brief Summary
This research trial studies biomarkers in predicting treatment response in samples from
patients with early-stage non-small cell lung cancer previously treated with adjuvant
chemotherapy. Studying samples of tissue from patients with cancer in the laboratory may
help doctors learn more about changes that occur in DNA and identify biomarkers related
to cancer. It may also help doctors predict how patients will respond to treatment.
Detailed Description
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.
Enrollment Count
950 participants
Eligibility Criteria
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
Filters
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
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