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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01414595
First received: August 10, 2011
Last updated: June 27, 2016
Last verified: June 2016
  Purpose

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.


Condition Intervention
Lung Cancer
Genetic: DNA analysis
Genetic: DNA methylation analysis
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Molecular Characterization of Lung Cancer: A Collaboration With the Cancer Genome Atlas Project (TGCA)

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Identification and characterization of SNVs in primary adenocarcinoma of the lung or squamous cell carcinoma of the lung [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Identification and characterization of structural variations in the genomes of NSCLC [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Identification and characterization of other genomic alterations including, but not limited to, gene expression profiling and methylation [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Tumor and blood samples

Estimated Enrollment: 390
Study Start Date: March 2012
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Genetic: DNA analysis Genetic: DNA methylation analysis Genetic: RNA analysis Genetic: gene expression analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: medical chart review

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with lung cancer who are registered to CALGB-140202.
Criteria
  • Patient must have been registered to CALGB 140202.
  • Tumor histology should be either primary adenocarcinoma or squamous cell carcinoma of the lung.
  • Patients are eligible for this study if their samples from CALGB 140202 are available.
  • All living patients must sign the CALGB 151107 consent form to be eligible for this trial.
  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: NCT01414595

Contacts
Contact: Ramaswamy Govindan, MD 314-362-5737

Locations
United States, California
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Robert J. McKenna, MD    310-652-0530      
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center    302-645-3171      
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit    800-888-8823      
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Thomas L. Bauer, II    410-398-4000      
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ramaswamy Govindan, MD    314-362-4819      
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo    856-325-6757      
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute    877-275-7724      
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Cancer Institute    888-275-3853      
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C    401-444-1488      
Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Clinical Trials Office - Miriam Hospital    401-793-2224      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Ramaswamy Govindan, MD Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01414595     History of Changes
Other Study ID Numbers: CALGB-151107  CDR0000706375 
Study First Received: August 10, 2011
Last Updated: June 27, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the lung
adenosquamous cell lung cancer
non-small cell lung cancer
squamous cell lung cancer

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

ClinicalTrials.gov processed this record on December 02, 2016