Biomarkers in Predicting Treatment Response in Samples From Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy
Conditions
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
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: medical chart review Type: Other
Name: laboratory biomarker analysis Type: Other
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
National Cancer Institute of Canada Clinical Trials Group
Kingston, Ontario, Canada
Status: Not yet recruiting
Contact: Lesley K. Seymour - 613-533-6430 - lseymour@ctg.queensu.ca
Start Date
May 2012
Sponsors
National Cancer Institute (NCI)
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page