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

Lung Cancer Clinical Trial

Official title:

Molecular Characterization of Lung Cancer: A Collaboration With the Cancer Genome Atlas Project (TGCA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414595
• Other study ID #: CALGB-151107
• Secondary ID: CALGB-151107CDR0
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: June 26, 2017
• Start date: March 2012

Study information

• Verified date: June 2017
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• DNA analysis

• DNA methylation analysis

• RNA analysis

• gene expression analysis

• polymorphism analysis

Other:
• laboratory biomarker analysis

• medical chart review

Locations

Country	Name	City	State
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Duke Cancer Institute	Durham	North Carolina
United States	Union Hospital of Cecil County	Elkton	Maryland
United States	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware
United States	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Miriam Hospital	Providence	Rhode Island
United States	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification and characterization of SNVs in primary adenocarcinoma of the lung or squamous cell carcinoma of the lung		up to 5 years
Primary	Identification and characterization of structural variations in the genomes of NSCLC		up to 5 years
Primary	Identification and characterization of other genomic alterations including, but not limited to, gene expression profiling and methylation		up to 5 years