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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Purpose
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
| Condition | Intervention |
|---|---|
|
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 |
Genetic: gene expression analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: reverse transcriptase-polymerase chain reaction Other: Fourier transform ion cyclotron resonance mass spectrometry Other: medical chart review Other: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Observational - The Identification, Validation and Implemention of Prognostic and/or Predictive Biomarkers for Adjuvant Chemotherapy in Early Stage Non-Small Cell Lung Cancer (NSCLC) |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 950 |
| Study Start Date: | May 2012 |
| Estimated Primary Completion Date: | January 2100 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Diagnostic (biomarker 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.
|
Genetic: gene expression analysis
Correlative studies
Genetic: microarray analysis
Correlative studies
Other Name: gene expression profiling
Genetic: mutation analysis
Correlative studies
Genetic: reverse transcriptase-polymerase chain reaction
Correlative studies
Other Name: RT-PCR
Other: Fourier transform ion cyclotron resonance mass spectrometry
Correlative studies
Other: medical chart review
Correlative studies
Other Name: chart review
Other: laboratory biomarker analysis
Correlative studies
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Ontario | |
| National Cancer Institute of Canada Clinical Trials Group | Not yet recruiting |
| Kingston, Ontario, Canada, K7L 3N6 | |
| Contact: Lesley K. Seymour 613-533-6430 lseymour@ctg.queensu.ca | |
| Principal Investigator: Lesley K. Seymour | |
| Principal Investigator: | Lesley Seymour | NCIC Clinical Trials Group |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01595074 History of Changes |
| Other Study ID Numbers: | NCI-2012-01965, LACE-BIO-2#1 |
| Study First Received: | May 8, 2012 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013