NCT00900328已完成不适用
A Pilot Project to Study the Expression of c-MET and p53 in Resected Lung Adenocarcinoma Specimens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- c-Met expression
研究概览
简要总结
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.
详细描述
OBJECTIVES:
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- 未提供
结局指标
主要结局
c-Met expression
时间窗: Baseline
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.
次要结局
- EMT expression(Baseline)
- Mutations in EGFR, Kras, p53, and c-CBL(Baseline)
- Circulating c-Met and HGF in AC(Baseline)
- c-CBL expression and LOH(Baseline)
- DUB3 expression and regulation(Baseline)
- ALK Translocation(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)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
S9313B Study of Tumor Tissue Samples From Women With Early-Stage Breast Cancer Enrolled on Clinical Trial SWOG-9313Breast CancerNCT00949013SWOG Cancer Research Network1,600
已完成
不适用
DNA Analysis of Tumor Tissue From Patients With Acute Myeloid LeukemiaLeukemiaNCT00897936ECOG-ACRIN Cancer Research Group418
Unknown
不适用
Cancer Stem Cell Biomarkers as a Predictor of Response to Trastuzumab in Samples From Patients With Breast Cancer Previously Treated in the NSABP-B-31 TrialBreast CancerNCT01424865NSABP Foundation Inc1,874
Unknown
不适用
Isotretinoin in Treating Young Patients With High-Risk NeuroblastomaNeuroblastomaNCT00939965Children's Cancer and Leukaemia Group75
已完成
2 期
Study of Tumor Tissue Testing in Selecting Treatment for Patients With Metastatic or Locally Advanced Colorectal CancerColorectal CancerNCT00975897Medical Research Council3,240