Clinical trial NCT00900328: Study of Tumor Samples From Patients With Lung Cancer
Official title: A Pilot Project to Study the Expression of c-MET and p53 in Resected Lung Adenocarcinoma Specimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: adenocarcinoma of the lung
recurrent non-small cell lung cancer
stage 0 non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung adenocarcinoma enrolled on CALCB 140202

Brief summary: 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.

Detailed description: 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.

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.

Eligibility criteria: 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

  * 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

Primary outcomes:
measure: c-Met expression
timeFrame: Baseline
Secondary outcomes:
measure: EMT expression
timeFrame: Baseline
measure: Mutations in EGFR, Kras, p53, and c-CBL
timeFrame: Baseline
measure: c-CBL expression and LOH
timeFrame: Baseline
measure: DUB3 expression and regulation
timeFrame: Baseline
measure: ALK Translocation
timeFrame: Baseline
measure: Circulating c-Met and HGF in AC
timeFrame: Baseline
measure: Prognostic implications of circulating markers in AC of lung
timeFrame: Baseline
measure: Levels of circulating Met and HGF in serum before and after surgery (when available)
timeFrame: At time of surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: University of Chicago
state: Massachusetts
Study officials:
affiliation: University of Chicago
name: Ravi Salgia, MD, PhD
role: STUDY_CHAIR
References: