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NCT01503619 Clinical Trial

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

Lung Cancer Clinical Trial

Official title:
Genomics of Small Cell Lung Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01503619
Other study ID # CALGB-151111
Secondary ID CDR0000721552NCI
Status Completed
Phase
First received
Last updated
Start date January 2012
Est. completion date February 27, 2019

Study information
Verified date August 2021
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date February 27, 2019
Est. primary completion date February 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations
Country Name City State
United States Fred Hutchinson Cancer Research Center Seattle Washington

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of genetic alterations in human SCLC (driver or passenger mutations) Baseline
Secondary Gene expression between samples with or without mutations Baseline
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