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

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ClinicalTrials.gov Identifier: NCT01414595
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
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

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.


Study Design

Study Type : Observational
Actual Enrollment : 248 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Molecular Characterization of Lung Cancer: A Collaboration With the Cancer Genome Atlas Project (TGCA)
Study Start Date : March 2012
Primary Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Identification and characterization of SNVs in primary adenocarcinoma of the lung or squamous cell carcinoma of the lung [ Time Frame: up to 5 years ]
  2. Identification and characterization of structural variations in the genomes of NSCLC [ Time Frame: up to 5 years ]
  3. Identification and characterization of other genomic alterations including, but not limited to, gene expression profiling and methylation [ Time Frame: up to 5 years ]

Biospecimen Retention:   Samples With DNA
Tumor and blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414595


Locations
United States, California
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Union Hospital of Cecil County
Elkton, Maryland, United States, 21921
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
Miriam Hospital
Providence, Rhode Island, United States, 02906
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

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01414595     History of Changes
Other Study ID Numbers: CALGB-151107
CDR0000706375 ( Registry Identifier: NCI Physician Reference Desk )
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

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