Collection and Storage of Blood and Tissue Samples From Patients Who Are Undergoing Surgery For Lung Cancer

This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899782
First received: May 9, 2009
Last updated: February 10, 2013
Last verified: February 2013
  Purpose

RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: The purpose of this study is to collect and store tissue and blood samples from patients with lung cancer to be tested in the laboratory.


Condition Intervention
Lung Cancer
Other: biologic sample preservation procedure

Study Type: Observational
Official Title: The CALGB Lung Cancer Tissue Bank

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Collection and storage of frozen specimens of tumor, involved lymph node (when available), and grossly uninvolved adjacent lung tissues obtained from patients during surgical staging or resection of lung cancer [ Designated as safety issue: No ]
  • Collection and storage of frozen blood samples from these patients as a source of reference DNA to assess somatic mutations associated with tumor or preneoplastic "normal" lung and to assess levels of circulating markers [ Designated as safety issue: No ]
  • Correlation of these analyses with historical, clinical, pathological, and outcome information [ Designated as safety issue: No ]

Study Start Date: July 2004
Detailed Description:

OBJECTIVES:

  • Collect and store frozen specimens of tumor, involved lymph node (when available), and grossly uninvolved adjacent lung tissues obtained from patients during surgical staging or resection of lung cancer, for later molecular analysis.
  • Collect and store frozen blood samples from these patients, as a source of reference DNA to assess somatic mutations associated with tumor or preneoplastic "normal" lung and to assess levels of circulating markers.
  • Correlate these analyses with historical, clinical, pathological, and outcome information.

OUTLINE: Grossly viable tumor and grossly normal lung tissue are identified and removed from patient surgical specimens and cryopreserved until shipment to the CALGB Lung Cancer Tissue Bank for future use in research. Blood specimens are obtained pre- or intra-operatively and shipped immediately to the Tissue Bank.

Patients do not receive the results of the research.

PROJECTED ACCRUAL: Samples from approximately 100 patients per year will be collected for at least 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Suspected or histologically confirmed lung cancer
  • Undergoing surgical staging or resection of tumor at a CALGB Lung Cancer Tissue Bank-approved institution
  • No concurrent enrollment on clinical study CALG 140203, intraoperative sentinal node mapping in non-small cell lung cancer

PATIENT CHARACTERISTICS:

  • No known infectious disease (e.g., HIV, tuberculosis, or hepatitis B or C)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899782

Locations
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
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Thomas L. Bauer, II     410-398-4000        
United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Clinical Trials Office     617-724-5200        
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Raphael Bueno     617-632-3474        
United States, Minnesota
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o     612-624-2620        
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia Recruiting
Columbia, Missouri, United States, 65203
Contact: Clinical Trial Office - Ellis Fischel Cancer Center     573-882-7440        
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Traves D. Crabtree     314-747-7222        
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        
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi     315-464-5476        
United States, North Carolina
Veterans Affairs Medical Center - Asheville Recruiting
Asheville, North Carolina, United States, 28805
Contact: John C. Lucke, MD     828-299-2540        
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Cancer Institute     888-275-3853        
United States, Pennsylvania
Forbes Regional Hospital Recruiting
Monroeville, Pennsylvania, United States, 15146
Contact: Robert J. Keenan, MD     412-359-6202        
Alle-Kiski Medical Center Recruiting
Natrona Heights, Pennsylvania, United States, 15065
Contact: Robert J. Keenan, MD     412-359-6202        
Allegheny Cancer Center at Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Robert J. Keenan, MD     412-359-6202        
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        
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Health Care     802-656-8990        
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: David J. Sugarbaker, MD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00899782     History of Changes
Other Study ID Numbers: CDR0000271323, CALGB-140202
Study First Received: May 9, 2009
Last Updated: February 10, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer
small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013