Study of Tissue Samples From Patients With Non-Small Cell Lung Cancer

NCT ID: NCT01414595

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

248 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Brief Summary

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RATIONALE: Studying samples of tissue 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 trial studies tissue samples from patients with non-small cell lung cancer.

Detailed Description

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OBJECTIVES:

* To identify and characterize single nucleotide variations (SNVs) in non-small cell lung cancer (NSCLC) specimens.
* To identify and characterize structural variations in the genomes of NSCLC specimens.
* To identify and characterize other genomic alterations including, but not limited to, expression profiling and methylation.

OUTLINE: DNA and RNA extracted from archived specimens are analyzed for single nucleotide variations, structural variations in the genomes, and other genomic alterations including, but not limited to, gene expression profiling and methylation. Clinical data related to disease, treatment, and recurrence from each patient sample is also collected.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

CALGB 140202 outlines the standard procedures for sample procurement. Samples to be used for this project have already been obtained and are currently banked at the CALGB Pathology Coordinating Office (PCO) and the Lung Cancer Tissue Bank at Brigham and Women's Hospital.

DNA analysis

Intervention Type GENETIC

DNA methylation analysis

Intervention Type GENETIC

RNA analysis

Intervention Type GENETIC

gene expression analysis

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

medical chart review

Intervention Type OTHER

Interventions

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DNA analysis

Intervention Type GENETIC

DNA methylation analysis

Intervention Type GENETIC

RNA analysis

Intervention Type GENETIC

gene expression analysis

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

medical chart review

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All living patients must sign the CALGB 151107 consent form to be eligible for this trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ramaswamy Govindan, MD

Role: STUDY_CHAIR

Washington University School of Medicine

Locations

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Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Union Hospital of Cecil County

Elkton, Maryland, United States

Site Status

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Site Status

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Duke Cancer Institute

Durham, North Carolina, United States

Site Status

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, United States

Site Status

Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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CALGB-151107

Identifier Type: -

Identifier Source: secondary_id

CDR0000706375

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-151107

Identifier Type: -

Identifier Source: org_study_id

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