Lung Cancer Clinical Trial; Carinal Biopsy Study

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Carinal Biopsy Study
This study is currently recruiting participants.
Verified by University of Pittsburgh, October 2008
Sponsors and Collaborators: University of Pittsburgh
National Institutes of Health (NIH)

Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00280202

Purpose
The purpose of the intended genetic research is to improve the diagnosis and prognosis of lung cancer patients as well as to identify genetic risk factors that may predict lung cancer risk.



Condition Intervention
Non-Small Cell Lung Cancer
Procedure: Biopsy of the major carinal area
Procedure: Biopsy of abnormal & suspicious areas of the bronchial tree
Procedure: Evaluation of the tumor for DNA mutations
Procedure: Bronchoalveolar Lavage (BAL) for cytokine analysis
Procedure: Correlation of flow cytometric & RT PCR for TNM stage
Procedure: Analysis of lymph nodes




MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Detection of Genetic Markers of Lung Cancer Initiation and Progression


Further study details as provided by University of Pittsburgh:


Primary Outcome Measures:
To detect genetic markers of lung cancer initiation and progression in tissue obtained during bronchoscopy. [ Time Frame: No specific time frame ] [ Designated as safety issue: No ]

To identify genetic risk factors that may predict lung cancer risk. [ Time Frame: No specific time frame ] [ Designated as safety issue: No ]



Secondary Outcome Measures:
To obtain/maintain in cell culture "normal" bronchial epithelial cells(NBECs) and tumors from subjects undergoing resection for cure of bronchogenic non-small cell lung cancer(NSCLC). [ Time Frame: No specific time frame ] [ Designated as safety issue: No ]

To harvest NBEC and lung tumors for evaluation of genetic abnormalities; this will be obtained at the time of bronchoscopy and lung resection. [ Time Frame: No specific time frame ] [ Designated as safety issue: No ]

To perform polymerase chain reaction(PCR) amplification of DNA harvested from NBECs,tumors,adjacent & normal lung, & white blood cells as a control for evaluation for mutations in the K-ras & p53 protooncogenes,& other candidate lung cancer genes. [ Time Frame: No specific time frame ] [ Designated as safety issue: No ]

To look for mutations and alterations of expression of Fas, Fas ligand, and FADD, three molecules which mediate programmed cell death and have recently been shown to be expressed on multiple tumor cells including lung cancer. [ Time Frame: No specific time frame ] [ Designated as safety issue: No ]

To analyze cytokines present in lavage fluid, tumors, and lung tissues; this will be obtained at the time of bronchoscopy. [ Time Frame: No specific time frame ] [ Designated as safety issue: No ]

To produce T cell cultures from cells present in tumor-draining lymph nodes. [ Time Frame: No specific time frame ] [ Designated as safety issue: No ]

To use these cultures to identify carcinoembryonic antigen(CEA), cytokeratin-19, hepatocyte growth factor, gastrin-releasing peptide(GRP)receptor, and the neuromedin-B(NMB) receptor as potential for evidence of micrometastases. [ Time Frame: No specific time frame ] [ Designated as safety issue: No ]

To detect metastatic tumor in bone marrow extracted from discarded rib resection material which is sometimes removed for access during resection of the lung. [ Time Frame: No specific time frame ] [ Designated as safety issue: No ]


Biospecimen Retention: Samples With DNA


Biospecimen Description:
Blood, tissue, and lymph nodes


Estimated Enrollment: 4000
Study Start Date: June 1996

Intervention Details:
Procedure: Biopsy of the major carinal area
Biopsy performed intraoperatively
Procedure: Biopsy of abnormal & suspicious areas of the bronchial tree
Biopsy performed intraoperatively
Procedure: Evaluation of the tumor for DNA mutations
Tumor tissue is banked for future analysis.
Procedure: Bronchoalveolar Lavage (BAL) for cytokine analysis
BAL performed intraoperatively
Procedure: Correlation of flow cytometric & RT PCR for TNM stage
Tissues banked for future correlative studies
Procedure: Analysis of lymph nodes
Tissues banked for future analysis
Show Detailed Description


Eligibility


Ages Eligible for Study: 18 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population
Eligible patients will be selected from investigator's clinic.

Criteria
Inclusion Criteria:

Histologic confirmation of non-small cell lung cancer or a radiographic lesion highly suspicious for malignancy
Written informed consent.
Must be scheduled for a rigid bronchoscopy with surgical resection (thoracoscopic or laser resection of parenchymal lesions or thoracotomy).
Exclusion Criteria:

Subjects scheduled for only a surgical resection.
Subjects with any "other" prior cancer (other than lung) within 5 years of date of surgery are NOT eligible (unless there is preoperative pathologic confirmation that the lung mass is a second primary cancer)
Subjects with any type of lung cancer other than non-small cell lung cancer(NSCLC)
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280202


Contacts
Contact: Jill Siegfried, PhD 412-648-1942
Contact: Julie Ward, BSN 412-647-8583 wardj@upmc.edu


Locations
United States, Pennsylvania
Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15116
Principal Investigator: Jill Siegfried, PhD
Sub-Investigator: James D. Luketich, MD
Sub-Investigator: Rodney J. Landreneau, MD
Sub-Investigator: Tony E. Godfrey, PhD
Sub-Investigator: Samuel Yousem, MD
Sub-Investigator: Neil A. Christie, MD
Sub-Investigator: Matthew Schuchert, MD
Sub-Investigator: Miguel F. Alvelo-Rivera, MD
Sub-Investigator: Sebastien Gilbert, MD
Sub-Investigator: Brian Pettiford, MD
Sub-Investigator: Ghulam Abbas, MD
Sub-Investigator: Vera S. Donnenberg, PhD
Sub-Investigator: Kenneth McCurry, MD
Sub-Investigator: William Bigbee, PhD
Sub-Investigator: Rajiv Dhir, MD
Sub-Investigator: Talal El-Hefnawy, MD PhD
Sub-Investigator: Arjun Pennathur, MD

Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jill Siegfried, PhD Professor of Pharmacology, University of Pittsburgh

More Information

Responsible Party: University of Pittsburgh ( Jill Siegfried, Ph.D. )
Study ID Numbers: 9502100, UPCI #99-053
Study First Received: January 18, 2006
Last Updated: October 13, 2008
ClinicalTrials.gov Identifier: NCT00280202 [history]
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Non-small cell lung cancer
Carcinogenesis
Genomic changes leading to malignant phenotypes in NSCLC.
Simultaneous mutagenesis of epithelial cells.
Chromosomal abnormalities/mutations in bronchial tissues.
Detect micrometastases in histologically neg. lymph nodes



Study placed in the following topic categories:
Thoracic Neoplasms
Chromosomal abnormalities
Non-small cell lung cancer
Chromosome Disorders
Disease Progression
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Chromosome Aberrations
Congenital Abnormalities
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type



ClinicalTrials.gov processed this record on February 10, 2009


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