Clinical trial NCT01414595: Study of Tissue Samples From Patients With Non-Small Cell Lung Cancer
Official title: Molecular Characterization of Lung Cancer: A Collaboration With the Cancer Genome Atlas Project (TGCA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: adenocarcinoma of the lung
adenosquamous cell lung cancer
non-small cell lung cancer
squamous cell lung cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-08-11
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with lung cancer who are registered to CALGB-140202.

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.

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 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.

Primary outcomes:
measure: Identification and characterization of SNVs in primary adenocarcinoma of the lung or squamous cell carcinoma of the lung
timeFrame: up to 5 years
measure: Identification and characterization of structural variations in the genomes of NSCLC
timeFrame: up to 5 years
measure: Identification and characterization of other genomic alterations including, but not limited to, gene expression profiling and methylation
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
state: California
city: Lewes
country: United States
facility: Tunnell Cancer Center at Beebe Medical Center
state: Delaware
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Baltimore
country: United States
facility: Greenebaum Cancer Center at University of Maryland Medical Center
state: Maryland
city: Elkton
country: United States
facility: Union Hospital of Cecil County
state: Maryland
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
city: Voorhees
country: United States
facility: Cancer Institute of New Jersey at Cooper - Voorhees
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Providence
country: United States
facility: Rhode Island Hospital Comprehensive Cancer Center
state: Rhode Island
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Washington University School of Medicine
name: Ramaswamy Govindan, MD
role: STUDY_CHAIR
References: