Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Detection of Genetic Markers of Lung Cancer

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. Identifier: NCT00280202
Recruitment Status : Recruiting
First Posted : January 20, 2006
Last Update Posted : November 19, 2021
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Arjun Pennathur, University of Pittsburgh

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
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

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 6000 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

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

Primary Outcome Measures :
  1. The odds ratio for the risk of lung cancer associated with molecular markers [ 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 and circulating tumor DNA (ctDNA) in biological samples and correlate with imaging analysis and outcomes. [ Time Frame: No specific time frame ]
  10. To conduct genomic, proteomic, metabolomic, microbiome, and immunologic research studies on samples collected [ Time Frame: No specific time frame ]

Biospecimen Retention:   Samples With DNA
Blood, tissue, and lymph nodes

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
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.

Inclusion Criteria:

  • Histologic confirmation of lung cancer, lung metastases from a primary site other than lung, mesothelioma or a radiographic lesion highly suspicious for malignancy
  • Written informed consent.
  • Must be scheduled for a biopsy or surgical resection

Exclusion Criteria:


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 identifier (NCT number): NCT00280202

Layout table for location contacts
Contact: Arjun Pennathur, MD 412-647-7555
Contact: Julie Ward, BSN 412-647-8583

Layout table for location information
United States, Pennsylvania
Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Julie A Ward, BSN    412-647-8583   
Contact: Judy Forster, BSN    412-647-8579   
Sub-Investigator: James D. Luketich, MD         
Sub-Investigator: Neil A. Christie, MD         
Sub-Investigator: Matthew Schuchert, MD         
Sub-Investigator: Vera S. Donnenberg, PhD         
Sub-Investigator: Rajiv Dhir, MD         
Principal Investigator: Arjun Pennathur, MD         
Sub-Investigator: Lawrence Crist, DO         
Sub-Investigator: Ryan Levy, MD         
Sub-Investigator: Liza Villaruz, MD         
Sub-Investigator: Timothy Burns, MD         
Sub-Investigator: Rajeev Dhupar, MD         
Sub-Investigator: Inderpal Sarkaria, MD         
Sub-Investigator: Omar Awais, DO         
Sub-Investigator: Nicholas Baker, MD         
Sub-Investigator: William Gooding         
Sub-Investigator: Witek Tadeusz, MD         
Sub-Investigator: Wilson David, MD         
Sub-Investigator: Laura Stabile, PhD         
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
Layout table for investigator information
Principal Investigator: Arjun Pennathur, MD Associate Professor of Cardiothoracic Surgery and Critical Care Medicine
Layout table for additonal information
Responsible Party: Arjun Pennathur, MD, University of Pittsburgh Identifier: NCT00280202    
Other Study ID Numbers: 19060269
UPCI #99-053 ( Other Identifier: UPittsburgh Cancer Institute Protocol Review Committee )
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Lung cancer
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:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action