Detection of Genetic Markers of Lung Cancer

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of lung cancer.

Condition or disease	Intervention/treatment
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

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Study Design

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Study Type :	Observational
Estimated Enrollment :	4000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Detection of Genetic Markers of Lung Cancer Initiation and Progression
Study Start Date :	June 1996
Estimated Primary Completion Date :	December 2050
Estimated Study Completion Date :	December 2050

Groups and Cohorts

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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

Outcome Measures

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Primary Outcome Measures :

1. To detect genetic markers of lung cancer initiation and progression [ Time Frame: No specific time frame ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. To perform molecular analysis including PCR amplification, flow cytometry, immunohistochemistry, and gene analysis from NBECs, tumors, adjacent & normal lung, and blood. [ Time Frame: No specific time frame ]
4. 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 ]
5. To analyze cytokines present in lavage fluid, tumors, and lung tissues. [ Time Frame: No specific time frame ]
6. To produce T cell cultures from cells present in tumor-draining lymph nodes and in tumor tissue. To isolate, numerically expand as well as phenotypically and functionally characterize human tumor-infiltrating lymphocytes (TILs) and tumor cells. [ Time Frame: No specific time frame ]
7. To analyze intra-pulmonary and mediastinal lymph nodes for expression of tumor related mRNAs (such as CEA and cytokeratin-19) as potential evidence of micrometastases. [ Time Frame: No specific time frame ]
8. 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 ]
9. To analyze biomarkers in biological samples and correlate with outcomes. [ Time Frame: No specific time frame ]

Biospecimen Retention:   Samples With DNA

Blood, tissue, and lymph nodes

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: Tony E. Godfrey, PhD
Sub-Investigator: Samuel Yousem, MD
Sub-Investigator: Neil A. Christie, MD
Sub-Investigator: Matthew Schuchert, MD
Sub-Investigator: Vera S. Donnenberg, PhD
Sub-Investigator: William Bigbee, PhD
Sub-Investigator: Rajiv Dhir, MD
Principal Investigator: Arjun Pennathur, MD
Sub-Investigator: Katie Nason, MD
Sub-Investigator: Jason Lamb, MD
Sub-Investigator: Lawrence Crist, DO
Sub-Investigator: Ryan Levy, MD
Sub-Investigator: Manisha Shende, MD
Sub-Investigator: Mark Socinski, MD
Sub-Investigator: Liza Villaruz, MD
Sub-Investigator: Joel Weissfeld, MD
Sub-Investigator: Vera Levina, PhD
Sub-Investigator: Timothy Burns, MD
Sub-Investigator: Rajeev Dhupar, MD
Sub-Investigator: Inderpal Sarkaria, MD
Sub-Investigator: Jonathan D'Cunha, MD
Sub-Investigator: Omar Awais, DO
Sub-Investigator: Manuel Villa Sanchez, MD
Sub-Investigator: Nicholas Baker, MD

Sponsors and Collaborators

University of Pittsburgh

National Institutes of Health (NIH)

Investigators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Arjun Pennathur, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00280202 History of Changes
Other Study ID Numbers:	9502100; UPCI #99-053
First Posted:	January 20, 2006
Last Update Posted:	October 4, 2017
Last Verified:	October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Arjun Pennathur, 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:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site	Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms