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

Lung Cancer Clinical Trial

Official title:

Isolation and Identification of Lung Cancer Precursor Cells From Malignant Pleural Effusion Specimens

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00897143
• Other study ID #: CASE1507
• Secondary ID: P30CA043703CASE1
• Status: Withdrawn
• Phase: N/A
• First received: May 9, 2009
• Last updated: October 8, 2015
• Start date: June 2007

Study information

• Verified date: October 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Genetic:
• microarray analysis
analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin
• 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
• immunologic technique
analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isolation and identification of lung cancer precursor cells in malignant pleural effusion specimens			No