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Identifying Early Lung Cancer Cells in Malignant Pleural Effusion Samples From Patients With Primary Lung Cancer

This study has been withdrawn prior to enrollment.
(PI Left)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00897143
First received: May 9, 2009
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

RATIONALE: Studying samples of pleural fluid in the laboratory from patients with lung cancer may help doctors identify early lung cancer cells. It may also help the study of lung cancer in the future.

PURPOSE: This laboratory study is looking at malignant pleural effusion samples from patients with primary lung cancer to see if early lung cancer cells can be identified.


Condition Intervention
Lung Cancer
Metastatic Cancer
 Genetic: microarray analysis
Genetic: mutation analysis
Other: flow cytometry
Other: immunologic technique

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Isolation and Identification of Lung Cancer Precursor Cells From Malignant Pleural Effusion Specimens

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Isolation and identification of lung cancer precursor cells in malignant pleural effusion specimens [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Malignant pleural effusion specimens from patients with primary lung cancer obtained from the Pathology Department at the University Hospitals of Cleveland.


Enrollment: 0
Study Start Date: June 2007
Intervention Details:
    Genetic: microarray analysis
    analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin
    Genetic: mutation analysis
    analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin
    Other: flow cytometry
    analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin
    Other: immunologic technique
    analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin
Detailed Description:

OBJECTIVES:

  • Isolate and identify lung cancer precursor cells in discarded pleural fluid specimens obtained during routine thoracentesis procedures for the diagnosis and treatment of malignant pleural effusions.

OUTLINE: Malignant pleural effusion specimens obtained from the Pathology Department at the University Hospitals of Cleveland are analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin. The isolated cells are then stained with fluorescent DNA binding dye, Hoechst 33342, and other markers (i.e., CD133, CD24/CD44) and sorted by flow cytometry into progenitor and nonprogenitor subpopulations. The sorted subpopulations are separated and examined functionally by in vitro and in vivo studies. Sphere culture studies are also performed on the sorted subpopulations. The specimens may also be utilized for transcriptional profiling studies, RNAi studies, and for the establishment of long-term cultures and cell lines. DNA is also isolated and stored from tumor and nonepithelial normal cell compartments for future genetic studies on known and unidentified genetic abnormalities contributing to the development of lung cancer, such as EGFR, ErbB2, K-ras, and p53 mutational status.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Malignant pleural effusion samples from patients with primary lung cancer.

Criteria

DISEASE CHARACTERISTICS:

  • Cytologically positive malignant pleural effusion secondary to primary small cell or non-small cell lung cancer
  • Recruited from the Division of Hematology/Oncology, the Multidisciplinary Thoracic Oncology Group of Ireland Cancer Center, or the inpatient or outpatient units of Case Medical Center-University Hospitals

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897143

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Balazs Halmos, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00897143     History of Changes
Other Study ID Numbers: CASE1507, P30CA043703, CASE1507
Study First Received: May 9, 2009
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
non-small cell lung cancer
malignant pleural effusion
small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Pleural Effusion
Pleural Effusion, Malignant
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Pleural Diseases
Pleural Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013