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Studying Biomarkers in Tumor Tissue and Blood Samples From Patients With Small Cell Lung Cancer Registered on CALGB-140202

This study is not yet open for participant recruitment.
Verified January 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01503619
First received: January 3, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted

January 3, 2012
January 3, 2012
February 2012
March 2012   (final data collection date for primary outcome measure)
Identification of genetic alterations in human SCLC (driver or passenger mutations) [ Designated as safety issue: No ]
Same as current
No Changes Posted
Differences in gene expression between samples with or without mutations [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Studying Biomarkers in Tumor Tissue and Blood Samples From Patients With Small Cell Lung Cancer Registered on CALGB-140202
Genomics of Small Cell Lung Carcinoma

RATIONALE: Studying samples of tumor tissue and blood 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 research study is studying biomarkers in tumor tissue and blood samples from patients with small cell lung cancer registered on CALGB-140202.

OBJECTIVES:

Primary

  • To identify the major genetic alterations in human small cell lung cancer (SCLC) using next-generation sequencing and focusing on mutations in coding sequence.

Secondary

  • To follow up with in-depth assessment of candidate oncogenes and tumor suppressor genes using gene expression analysis, cell culture systems, and murine models of SCLC.

OUTLINE: DNA isolated from archived tumor tissue and blood samples are analyzed for genetic mutations and gene expression profiling using Illumina exome sequencing. Results are compared with transcriptome of tumors (or cell lines) with and without the specific mutation. Cell culture studies overexpressing or inhibiting the genes of interest are also performed in a mouse model to identified potential drivers of small cell lung cancer.
Observational
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Lung Cancer
  • Genetic: DNA analysis
  • Genetic: gene expression analysis
  • Genetic: gene mapping
  • Genetic: mutation analysis
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
23
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March 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Patients must have been registered to CALGB-140202 trial in which tumor material (frozen tissue and paired blood specimens) is available
  • IRB review and approval at the institution where the laboratory work will be performed is required

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
18 Years and older
No
Not Provided
Not Provided
 
NCT01503619
CDR0000721552, CALGB-151111
Not Provided
Monica M. Bertagnolli, Cancer and Leukemia Group B
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Principal Investigator: David MacPherson, PhD Carnegie Institution for Science
National Cancer Institute (NCI)
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP