Detection of Genetic Markers of Lung Cancer

This study is currently recruiting participants.

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Contacts and Locations

Verified October 2017 by Arjun Pennathur, University of Pittsburgh

Sponsor:

ClinicalTrials.gov Identifier:

NCT00280202

First Posted: January 20, 2006

Last Update Posted: October 4, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Collaborator:

National Institutes of Health (NIH)

Information provided by (Responsible Party):

Arjun Pennathur, University of Pittsburgh

Purpose

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	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: lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Further study details as provided by Arjun Pennathur, University of Pittsburgh:

Primary Outcome Measures:

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

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 ]
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 ]
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 ]
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 ]
To analyze cytokines present in lavage fluid, tumors, and lung tissues. [ Time Frame: No specific time frame ]
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 ]
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 ]
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 ]
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


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: 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


Responsible Party:	Arjun Pennathur, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00280202 History of Changes
Other Study ID Numbers:	9502100 UPCI #99-053
First Submitted:	January 18, 2006
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

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