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Detection of Genetic Markers of Lung Cancer

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ClinicalTrials.gov Identifier: NCT00280202
Recruitment Status : Recruiting
First Posted : January 20, 2006
Last Update Posted : October 4, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts

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

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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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 Posted: January 20, 2006    Key Record Dates
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