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NCT Number: NCT01503619

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

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

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

    Time frame: Baseline

Secondary outcomes

  1. Gene expression between samples with or without mutations

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genomics of Small Cell Lung Carcinoma

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jan 4, 2012
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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