Study of Tissue Samples From Patients With Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified January 2013 by National Cancer Institute (NCI)
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01414595
First received: August 10, 2011
Last updated: January 24, 2013
Last verified: January 2013
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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 |
| 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 National Cancer Institute (NCI):
Primary Outcome Measures:
- Identification and characterization of SNVs in primary adenocarcinoma of the lung or squamous cell carcinoma of the lung [ Designated as safety issue: No ]
- Identification and characterization of structural variations in the genomes of NSCLC [ Designated as safety issue: No ]
- Identification and characterization of other genomic alterations including, but not limited to, gene expression profiling and methylation [ Designated as safety issue: No ]
| Estimated Enrollment: | 390 |
| Study Start Date: | March 2012 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Registration to CALGB-140202
- Patient's tumor histology must be either primary adenocarcinoma or squamous cell carcinoma of the lung
- All samples to be studied were obtained and stored as part of CALGB-140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Patient may not have received neo-adjuvant therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414595
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 | |
| Miriam Hospital | Recruiting |
| Providence, Rhode Island, United States, 02906 | |
| Contact: Clinical Trials Office - Miriam Hospital 401-793-2224 | |
| 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 | |
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
| Principal Investigator: | Ramaswamy Govindan, MD | Washington University Siteman Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01414595 History of Changes |
| Other Study ID Numbers: | CDR0000706375, CALGB-151107 |
| Study First Received: | August 10, 2011 |
| Last Updated: | January 24, 2013 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the lung adenosquamous cell lung cancer non-small cell lung cancer squamous cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013