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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention
Lung Cancer
Genetic: DNA analysis
Genetic: gene expression analysis
Genetic: gene mapping
Genetic: mutation analysis
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Genomics of Small Cell Lung Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Identification of genetic alterations in human SCLC (driver or passenger mutations) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in gene expression between samples with or without mutations [ Designated as safety issue: No ]

Estimated Enrollment: 23
Study Start Date: February 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

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

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
  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: NCT01503619

Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Principal Investigator: David MacPherson, PhD Carnegie Institution for Science
  More Information

Additional Information:
No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT01503619     History of Changes
Other Study ID Numbers: CDR0000721552, CALGB-151111
Study First Received: January 3, 2012
Last Updated: January 3, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014