Study of Tumor Samples From Patients With Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00900328
First received: May 9, 2009
Last updated: March 30, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Lung Cancer
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: A Pilot Project to Study the Expression of c-MET and p53 in Resected Lung Adenocarcinoma Specimens

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlation of c-Met expression and stage and overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of c-Met expression and and biomarkers with survival [ Designated as safety issue: No ]
  • Correlation of c-Met expression and circulating c-Met and hepatocyte growth factor [ Designated as safety issue: No ]
  • Prognostic implications of circulating markers [ Designated as safety issue: No ]
  • Levels of circulating Met and HGF in serum before and after surgery (when available) [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: September 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of non-small cell lung cancer (NSCLC)

    • Adenocarcinoma
  • Enrolled in CALGB 140202
  • Must have undergone surgical staging or resection of NSCLC tumor with adequate diagnostic biopsy specimens and corresponding blood samples available at a CALGB Lung Cancer Tissue Bank-approved institution
  • Evaluable c-MET measures

PATIENT CHARACTERISTICS:

  • No known infectious disease (e.g., HIV, tuberculosis, or hepatitis B or C)

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900328

Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Ravi Salgia, MD, PhD University of Chicago
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00900328     History of Changes
Other Study ID Numbers: CDR0000614602, CALGB-150607
Study First Received: May 9, 2009
Last Updated: March 30, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014