NCT01414595

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

4.9 years

First QC Date

August 10, 2011

Last Update Submit

June 26, 2017

Conditions

Lung Cancer

Keywords

adenocarcinoma of the lungadenosquamous cell lung cancernon-small cell lung cancersquamous cell lung cancer

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

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.

Genetic: DNA analysisGenetic: DNA methylation analysisGenetic: RNA analysisGenetic: gene expression analysisGenetic: polymorphism analysisOther: laboratory biomarker analysisOther: medical chart review

Interventions

DNA analysisGENETIC
Group 1
DNA methylation analysisGENETIC
Group 1
RNA analysisGENETIC
Group 1
gene expression analysisGENETIC
Group 1
polymorphism analysisGENETIC
Group 1
laboratory biomarker analysisOTHER
Group 1
medical chart reviewOTHER
Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with lung cancer who are registered to CALGB-140202.

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Union Hospital of Cecil County

Elkton, Maryland, 21921, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, 02903, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor and blood samples

MeSH Terms

Conditions

Lung NeoplasmsAdenocarcinoma of LungCarcinoma, Non-Small-Cell Lung

Interventions

DNA MethylationGene Expression ProfilingAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaGenetic TechniquesInvestigative TechniquesDNA FingerprintingPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Ramaswamy Govindan, MD

    Washington University School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

March 1, 2012

Primary Completion

February 1, 2017

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

US(11)