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

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT01503619
Collaborator
National Cancer Institute (NCI) (NIH)
23
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: laboratory biomarker analysis

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.

Study Design

Study Type:
Observational
Actual Enrollment :
23 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Genomics of Small Cell Lung Carcinoma
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Feb 27, 2019
Actual Study Completion Date :
Feb 27, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

Other: laboratory biomarker analysis
Correlative studies

Outcome Measures

Primary Outcome Measures

  1. Identification of genetic alterations in human SCLC (driver or passenger mutations) [Baseline]

Secondary Outcome Measures

  1. Gene expression between samples with or without mutations [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: David MacPherson, PhD, Fred Hutchinson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01503619
Other Study ID Numbers:
  • CALGB-151111
  • CDR0000721552
  • NCI-2012-00104
First Posted:
Jan 4, 2012
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021
Keywords provided by Alliance for Clinical Trials in Oncology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2021