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
|
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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 |

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 |

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Procedure: Biopsy of the major carinal area
- To detect genetic markers of lung cancer initiation and progression [ Time Frame: No specific time frame ]
- 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

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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 |
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)

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
Contact: Arjun Pennathur, MD | 412-647-7555 | ||
Contact: Julie Ward, BSN | 412-647-8583 | wardj@upmc.edu |
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 |
Principal Investigator: | Arjun Pennathur, MD | Associate Professor of Cardiothoracic Surgery and Critical Care Medicine |
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 |