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

Completed

• Conditions: Lung Cancer
• Interventions: 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

• Registration Number: NCT01414595
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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.

Study Timeline

• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Study Start: 2012-03
• Primary Completion: 2017-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	gene expression analysis	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.
Group 1	polymorphism analysis	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.
Group 1	DNA analysis	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.
Group 1	RNA analysis	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.
Group 1	medical chart review	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.
Group 1	DNA methylation analysis	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.
Group 1	laboratory biomarker analysis	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.

Primary Outcome Measures

Name	Time	Method
Identification and characterization of SNVs in primary adenocarcinoma of the lung or squamous cell carcinoma of the lung	up to 5 years
Identification and characterization of structural variations in the genomes of NSCLC	up to 5 years
Identification and characterization of other genomic alterations including, but not limited to, gene expression profiling and methylation	up to 5 years

Trial Locations

Locations (11)

Union Hospital of Cecil County; 🇺🇸 Elkton, Maryland, United States

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Greenebaum Cancer Center at University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis; 🇺🇸 Saint Louis, Missouri, United States

Tunnell Cancer Center at Beebe Medical Center; 🇺🇸 Lewes, Delaware, United States

Cancer Institute of New Jersey at Cooper - Voorhees; 🇺🇸 Voorhees, New Jersey, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Rhode Island Hospital Comprehensive Cancer Center; 🇺🇸 Providence, Rhode Island, United States