Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | May 9, 2009 | ||||
| Last Updated Date | February 22, 2013 | ||||
| Start Date ICMJE | May 2001 | ||||
| Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Protein and RNA expression fingerprints from collected samples [ Time Frame: after collection of designated samples ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00897117 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer | ||||
| Official Title ICMJE | Molecular Fingerprinting of Lung Cancer | ||||
| Brief Summary | RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in RNA and identify biomarkers related to cancer. PURPOSE: This research study is collecting and analyzing lung tissue samples from patients undergoing surgery for non-small cell lung cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Any excess tissues removed from surgery and would otherwise be discarded (tissues not used for diagnosis and/or treatment decision making) are obtained for this study. Tissue are analyzed for molecular features that predict biologic behavior. Quantitation of RNA, gene expression profiles, and protein expression patterns are assessed by matrix-assisted laser desorption/ionization time of flight mass spectroscopy and microarray analysis. Medical records are reviewed to obtain information about results of tests associated with cancer diagnosis. Further progress in cancer treatment and tumor behavior after surgery are followed via record review. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Both prospective and retrospectives samples of blood and tissue. |
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| Sampling Method | Probability Sample | ||||
| Study Population | People who have clinical stage I and II non-small cell lung cancer |
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| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) | Resectable non-small cell lung cancer
Patients with clinical stage I or II invasive lung cancer that can be completely removed by surgery and who have not undergone chemotherapy or radiotherapy before surgery
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1200 | ||||
| Estimated Completion Date | July 2015 | ||||
| Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria
Exclusion criteria
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00897117 | ||||
| Other Study ID Numbers ICMJE | VICC THO 0136, P50CA090949, VU-VICC-THO-0136, P30CA068485 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center | ||||
| Study Sponsor ICMJE | Vanderbilt-Ingram Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt-Ingram Cancer Center | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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