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Trial record 3 of 3 for:    CALGB 140202

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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00899782
First received: May 9, 2009
Last updated: July 15, 2013
Last verified: July 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 Alliance for Clinical Trials in Oncology:

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 ]

Enrollment: 0
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899782

Locations
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Maryland
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States, 28805
Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Forbes Regional Hospital
Monroeville, Pennsylvania, United States, 15146
Alle-Kiski Medical Center
Natrona Heights, Pennsylvania, United States, 15065
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
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

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: July 15, 2013
Health Authority: Unspecified

Keywords provided by Alliance for Clinical Trials in Oncology:
non-small cell lung cancer
small cell lung cancer

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

ClinicalTrials.gov processed this record on November 20, 2014