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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000614602 | Registry Identifier | NCI Physician Data Query | |
| NCI-2009-00451 | Registry Identifier | NCI Clinical Trial Reporting Program | |
| U10CA180821 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Studying samples of tumor 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.
PURPOSE: This laboratory study is looking at tumor samples from patients with lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Previously collected tissue samples from patients enrolled in CALGB 140202 are assessed for mutation analysis of c-Met, EGFR, and K-ras. DNA is examined by PCR, followed by agarose gel electrophoresis; gene amplification of c-Met is examined by real time quantitative PCR; met/HF protein in serum is examined by ELISA; and c-Met, EGFR, p53, c-CBL, DUB3 enzyme, and ALK, and epithelial mesenchymal transition examined by IHC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancillary-Correlative (biomarkers in resected AC specimens) | Previously collected tissue samples from patients enrolled in CALGB 140202 are assessed for mutation analysis of c-Met, EGFR, Kras, p53, and c-CBL via standard PCR and sequencing; gene amplification of c-Met via real time quantitative PCR; LOH analysis of c-CBL; expression levels of met/HGF protein in serum via ELISA; and expression levels of c-Met, EGFR, p53, c-CBL, DUB3, ALK, and EMT via IHC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Correlative Studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| c-Met expression | The correlation of c-Met expression and stage will be tested using Fisher's exact test. The proportions of c-Met overexpressed in stage I and stage II or higher will be estimated as well as the confidence intervals. The correlation of c-Met expression and survival will be tested using log rank test. The hazard ratio and its confidence interval will be estimated using a Cox model with a single predictor. Summary statistics will be provided for all c-Met measures. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| EMT expression | The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points. |
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Inclusion Criteria:
Registration to Cancer and Leukemia Group B (CALGB) 140202
Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
Informed consent: the CALGB does not require that a separate consent form be signed for this study
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Patients with non-small cell lung adenocarcinoma enrolled on CALCB 140202
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Salgia, MD, PhD | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Tissue, serum
| Baseline |
| Mutations in EGFR, Kras, p53, and c-CBL | The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points. | Baseline |
| c-CBL expression and LOH | The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points. | Baseline |
| DUB3 expression and regulation | The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points. | Baseline |
| ALK Translocation | The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points. | Baseline |
| Circulating c-Met and HGF in AC | The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points. | Baseline |
| Prognostic implications of circulating markers in AC of lung | Baseline |
| Levels of circulating Met and HGF in serum before and after surgery (when available) | At time of surgery |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |