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Sponsors and Collaborators: |
James Graham Brown Cancer Center University of Louisville |
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Information provided by: | James Graham Brown Cancer Center |
ClinicalTrials.gov Identifier: | NCT00263731 |
The purpose of this study is to learn more about the metabolic properties of cancer cells of patients undergoing surgical removal of small cell and non-small cell lung cancer.
Condition | Intervention | Phase |
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Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung |
Other: 13-C-glucose |
Phase I |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Preoperative Metabolomic Analysis of Primary Lung Cancer: A Translational Clinical Trial of the Brown Cancer Center |
Estimated Enrollment: | 74 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Experimental Group: 27 subjects with NSCLC undergoing surgical resection, will receive glucose prior to surgery
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Other: 13-C-glucose
10 grams of 13C-glucose intravenously, as a 30-minute "piggyback" infusion, 2 to 6 hours prior to scheduled surgical resection of primary lung cancer.
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2
Control Group: 27 subjects with NSCLC undergoing surgical resection, will not receive glucose prior to surgery
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3
Healthy Control Group: 20 healthy subjects (must be asymptomatic, have no prior history of lung cancer or other cancer(s), and be a non-smoker) will provide 1 blood specimen.
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It has long been known that cancer cells absorb and break down substances in the body differently than healthy, non-cancer cells. This process of absorbing and breaking down substances is known as metabolism and is increased in cancer cells. Recent research suggests that this increased metabolic activity makes it easier for cancer cells to multiply. The objective of the study is to characterize the metabolism of glucose by the tumors of patients undergoing surgical resection of small cell and non-small cell lung cancer by serum metabolite analysis, using a variant of glucose (sugar) which makes up 1% of glucose in nature.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jamie M Day, BSN | 502-562-3429 | jmluka01@louisville.edu |
Contact: Kate K Rodger, MSHCM, BSN | (502) 562-3429 | kkrodg01@louisville.edu |
United States, Kentucky | |
James Graham Brown Cancer Center, University of Louisville | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Jamie M Day, BSN 502-562-3429 jmluka01@louisville.edu | |
Principal Investigator: Donald M Miller, MD, PhD |
Principal Investigator: | Donald M Miller, MD, PhD | James Graham Brown Cancer Center |
Responsible Party: | James Graham Brown Cancer Center ( Donald M. Miller, MD, PhD ) |
Study ID Numbers: | 523.05, BCC-LUN-05-002 |
Study First Received: | December 7, 2005 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00263731 |
Health Authority: | United States: Institutional Review Board |
lung cancer non-small cell lung cancer small cell lung cancer cancer metabolism |
Thoracic Neoplasms Non-small cell lung cancer Carcinoma, Neuroendocrine Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Neoplasms, Nerve Tissue |