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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01503619
First received: January 3, 2012
Last updated: June 24, 2016
Last verified: June 2016

January 3, 2012
June 24, 2016
January 2012
January 2100   (final data collection date for primary outcome measure)
Identification of genetic alterations in human SCLC (driver or passenger mutations) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Identification of genetic alterations in human SCLC (driver or passenger mutations) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01503619 on ClinicalTrials.gov Archive Site
Gene expression between samples with or without mutations [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Differences in gene expression between samples with or without mutations [ Designated as safety issue: No ]
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
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
Tissue, blood
Non-Probability Sample
Patients with small cell lung cancer enrolled on the Cancer and Leukemia Group B (CALGB) 140202 study
Lung Cancer
Other: laboratory biomarker analysis
Correlative studies
Basic science (biomarker analysis)
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.
Intervention: Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
23
Not Provided
January 2100   (final data collection date for primary outcome measure)
  • Patients must have been registered to CALGB-140202 trial in which tumor material (frozen tissue and paired blood specimens) is available
  • Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
Both
18 Years and older   (Adult, Senior)
No
Contact: David MacPherson, MD 206-667-6464
United States
 
NCT01503619
CALGB-151111, CDR0000721552, NCI-2012-00104
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: David MacPherson, PhD Fred Hutchinson Cancer Research Center
Alliance for Clinical Trials in Oncology
June 2016

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