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 : March 13, 2023
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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 |
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 |
- 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
- The odds ratio for the risk of lung cancer associated with molecular markers [ 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 and circulating tumor DNA (ctDNA) in biological samples and correlate with imaging analysis and outcomes. [ Time Frame: No specific time frame ]
- To conduct single cell analysis, genomic, proteomic, metabolomic, microbiome, tumor microenvironment, and immunologic research studies on samples collected. [ 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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
None
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 | pennathura@upmc.edu | |
Contact: Julie Ward, BSN | 412-647-8583 | wardj@upmc.edu |
United States, Pennsylvania | |
Hillman Cancer Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Julie A Ward, BSN 412-647-8583 wardj@upmc.edu | |
Contact: Judy Forster, BSN 412-647-8579 forsje@upmc.edu | |
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: 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 | |
Sub-Investigator: Kojo Agyabeng-Dadzie, MD | |
Sub-Investigator: Navid Ajabshir, MD | |
Sub-Investigator: Evan Alicuben, MD | |
Sub-Investigator: Ernest Chan, MD | |
Sub-Investigator: Rachel Deitz, MD | |
Sub-Investigator: Chigozirim Ekeke, MD | |
Sub-Investigator: Renee Levesque, 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 |
Other Study ID Numbers: |
STUDY19060269 UPCI #99-053 ( Other Identifier: UPittsburgh Cancer Institute Protocol Review Committee ) |
First Posted: | January 20, 2006 Key Record Dates |
Last Update Posted: | March 13, 2023 |
Last Verified: | March 2023 |
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 |
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 |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Dimercaprol Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |