Study of Tissue Samples From Patients With Non-Small Cell Lung Cancer
June 26, 2017 updated by: Alliance for Clinical Trials in Oncology
Molecular Characterization of Lung Cancer: A Collaboration With the Cancer Genome Atlas Project (TGCA)
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
248
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90048
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
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Delaware
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Lewes, Delaware, United States, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, United States, 19713
- CCOP - Christiana Care Health Services
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Maryland
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Baltimore, Maryland, United States, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Elkton, Maryland, United States, 21921
- Union Hospital of Cecil County
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Missouri
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Saint Louis, Missouri, United States, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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New Jersey
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Voorhees, New Jersey, United States, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Cancer Institute
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Miriam Hospital
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with lung cancer who are registered to CALGB-140202.
Description
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identification and characterization of SNVs in primary adenocarcinoma of the lung or squamous cell carcinoma of the lung
Time Frame: up to 5 years
|
up to 5 years
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Identification and characterization of structural variations in the genomes of NSCLC
Time Frame: up to 5 years
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up to 5 years
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Identification and characterization of other genomic alterations including, but not limited to, gene expression profiling and methylation
Time Frame: up to 5 years
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up to 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Ramaswamy Govindan, MD, Washington University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
August 10, 2011
First Submitted That Met QC Criteria
August 10, 2011
First Posted (Estimate)
August 11, 2011
Study Record Updates
Last Update Posted (Actual)
June 27, 2017
Last Update Submitted That Met QC Criteria
June 26, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CALGB-151107
- CDR0000706375 (Registry Identifier: NCI Physician Reference Desk)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.