Study of Tumor Samples From Patients With Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00900328
First received: May 9, 2009
Last updated: July 23, 2015
Last verified: July 2015
  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
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • c-Met expression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • EMT expression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Mutations in EGFR, Kras, p53, and c-CBL [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • c-CBL expression and LOH [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • DUB3 expression and regulation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • ALK Translocation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Circulating c-Met and HGF in AC [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Prognostic implications of circulating markers in AC of lung [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Levels of circulating Met and HGF in serum before and after surgery (when available) [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue, serum


Estimated Enrollment: 280
Study Start Date: September 2008
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: laboratory biomarker analysis
Correlative Studies

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
Sampling Method:   Non-Probability Sample
Study Population

Patients with non-small cell lung adenocarcinoma enrolled on CALCB 140202

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
  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

Contacts
Contact: Ravi Salgia, MD (773) 702-4399

Locations
United States, Massachusetts
Alliance for Clinical Trials in Oncology Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ravi Salgia, MD    773-702-4399      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Ravi Salgia, MD, PhD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00900328     History of Changes
Other Study ID Numbers: CALGB-150607, CDR0000614602, NCI-2009-00451, U10CA180821
Study First Received: May 9, 2009
Last Updated: July 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
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
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on July 30, 2015