Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
280 participants
OBSERVATIONAL
2008-09-30
2012-09-30
Brief Summary
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PURPOSE: This laboratory study is looking at tumor samples from patients with lung cancer.
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Detailed Description
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Primary
* To determine the correlation between c-Met expression, mutation and amplification, with stage and overall survival in patients with adenocarcinoma (AC) of the lung.
Secondary
* To determine the correlation with epithelial mesenchymal transition (EMT), EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, loss of heterozygosity (LOH), DUB3 expression \& regulation, and ALK translocation, with respect to survival.
* To determine the correlation with circulating c-Met and HGF in AC and evaluate prognostic implications of circulating markers in AC of lung.
* To determine (when available) levels of circulating Met and HGF in serum before and after surgery.
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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
laboratory biomarker analysis
Correlative Studies
Interventions
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laboratory biomarker analysis
Correlative Studies
Eligibility Criteria
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Inclusion Criteria
* 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
* The subject population to be studied in this protocol includes patients selected from CALGB 140202; all such patients have signed a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into that trial
* All samples to be studied were obtained and stored as part of CALGB 140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
* There should be no physical, psychological, social, or legal risks associated with this study; no invasive procedures are recommended or requested
* All appropriate and necessary procedures will be utilized to maintain confidentiality; all patients who have had samples submitted for analysis will have their CALGB study number used to identify specimens
* This study does not require direct patient contact and no specific risk or benefits to individuals involved in the trial are anticipated; it is likely, however, that the information gained will substantially help similar patients in the future
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Ravi Salgia, MD, PhD
Role: STUDY_CHAIR
University of Chicago
Locations
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University of Chicago
Boston, Massachusetts, United States
Countries
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Other Identifiers
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CDR0000614602
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2009-00451
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-150607
Identifier Type: -
Identifier Source: org_study_id
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