Metabolomic Analysis of Lung Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | December 7, 2005 | ||||
| Last Updated Date | January 14, 2013 | ||||
| Start Date ICMJE | December 2005 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
metabolic profiles of cancerous vs. healthy lung tissue [ Time Frame: after 13-C-glucose infusion ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00263731 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 | Metabolomic Analysis of Lung Cancer | ||||
| Official Title ICMJE | Preoperative Metabolomic Analysis of Primary Lung Cancer: A Translational Clinical Trial of the Brown Cancer Center | ||||
| Brief Summary | The purpose of this study is to learn more about the metabolic properties of lung cancer cells. |
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| Detailed Description | 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 lung tumors by serum metabolite analysis, using a variant of glucose (sugar) which makes up 1% of glucose in nature. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population |
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| Condition ICMJE |
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| Intervention ICMJE | Other: 13-C-glucose
10 grams of 13-C-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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| Study Group/Cohort (s) |
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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 | 750 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Lung Cancer Patients (Groups 1 & 2) Inclusion Criteria:
Exclusion Criteria:
Healthy Subjects (Group 3) Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00263731 | ||||
| Other Study ID Numbers ICMJE | 523.05, BCC-LUN-05-002 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | James Graham Brown Cancer Center | ||||
| Study Sponsor ICMJE | James Graham Brown Cancer Center | ||||
| Collaborators ICMJE | University of Louisville | ||||
| Investigators ICMJE |
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| Information Provided By | James Graham Brown Cancer Center | ||||
| Verification Date | January 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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