Metabolomic Analysis of Lung Cancer
The purpose of this study is to learn more about the metabolic properties of lung cancer cells.
Carcinoma, Non-Small Cell Lung
Carcinoma, Small Cell Lung
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Preoperative Metabolomic Analysis of Primary Lung Cancer: A Translational Clinical Trial of the Brown Cancer Center|
- metabolic profiles of cancerous vs. healthy lung tissue [ Time Frame: after 13-C-glucose infusion ] [ Designated as safety issue: No ]
- glycolytic metabolism in plasma [ Time Frame: before and after 13-C-glucose infusion ] [ Designated as safety issue: No ]
- metabolic markers in urine [ Time Frame: collected during surgery ] [ Designated as safety issue: No ]
- metabolic markers in serum [ Time Frame: before and after 13-C-glucose infusion ] [ Designated as safety issue: No ]
- metabolic markers in bronchoalveolar fluid [ Time Frame: during diagnostic bronchoscopy or during surgery ] [ Designated as safety issue: No ]
- metabolic markers in expired breath [ Time Frame: during surgery ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Group 1 (Experimental Group)
250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will receive 13-C-glucose prior to surgery
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.
Group 2 (Control Group)
250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will not receive 13-C-glucose prior to surgery
Group 3 (Healthy Subjects)
250 healthy subjects (must be at least 30 years of age and have no prior history of diagnosed lung cancer) will provide 1 blood sample and 1 urine sample.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263731
|Contact: Clinical Trials Office, Brown Cancer Centerfirstname.lastname@example.org|
|United States, Kentucky|
|James Graham Brown Cancer Center, University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator: Donald M Miller, MD, PhD|
|Principal Investigator:||Donald M Miller, MD, PhD||James Graham Brown Cancer Center|