Carinal Biopsy Study - Full Text View

Sponsor:	University of Pittsburgh
Collaborator:	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

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Detection of Genetic Markers of Lung Cancer Initiation and Progression

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

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

Blood, tissue, and lymph nodes

Estimated Enrollment:	4000
Study Start Date:	June 1996

Intervention Details:

Biopsy performed intraoperatively

Tumor tissue is banked for future analysis.

BAL performed intraoperatively

Tissues banked for future correlative studies

Tissues banked for future analysis

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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

No publications provided

Responsible Party:	Jill Siegfried, Ph.D., University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00280202 History of Changes
Other Study ID Numbers:	9502100, UPCI #99-053
Study First Received:	January 18, 2006
Last Updated:	January 12, 2010
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

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012