Detection of Genetic Markers of Lung Cancer - Full Text View

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:

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
Estimated Study Completion Date:	December 2050
Estimated Primary Completion Date:	December 2050 (Final data collection date for primary outcome measure)

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

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, mesothelioma or a radiographic lesion highly suspicious for malignancy
Written informed consent.
Must be scheduled for a biopsy or surgical resection

Exclusion Criteria:

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

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: NCT00280202

Contacts


Contact: Arjun Pennathur, MD	412-647-7555
Contact: Julie Ward, BSN	412-647-8583	wardj@upmc.edu

Locations


United States, Pennsylvania
Hillman Cancer Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Sub-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: Ghulam Abbas, MD
Sub-Investigator: Vera S. Donnenberg, PhD
Sub-Investigator: William Bigbee, PhD
Sub-Investigator: Rajiv Dhir, MD
Sub-Investigator: Talal El-Hefnawy, MD PhD
Principal Investigator: Arjun Pennathur, MD
Sub-Investigator: Katie Nason, MD
Sub-Investigator: Jason Lamb, MD
Sub-Investigator: Benny Weksler, MD
Sub-Investigator: Lawrence Crist, MD
Sub-Investigator: Ryan Levy, MD
Sub-Investigator: Manisha Shende, MD
Sub-Investigator: Mark Socinski, MD
Sub-Investigator: Liza Villaruz, MD
Sub-Investigator: Malini Srinivasan, MD
Sub-Investigator: Joel Weissfeld, MD
Sub-Investigator: Vera Levina, PhD
Sub-Investigator: Tony Godfrey, PhD
Sub-Investigator: Stephanie Land
Sub-Investigator: Chimeremma Nnadi
Sub-Investigator: Timothy Burns, MD

Sponsors and Collaborators

University of Pittsburgh

National Institutes of Health (NIH)

Investigators


Principal Investigator:	Arjun Pennathur, MD	Assistant Professor of Cardiothoracic Surgery and Critical Care Medicine

More Information

No publications provided


Responsible Party:	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:	February 12, 2014
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 Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases	Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

ClinicalTrials.gov processed this record on March 02, 2015