Metabolomic Analysis of Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to learn more about the metabolic properties of lung cancer cells.

Detailed Description
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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 lung tumors by serum metabolite analysis, using a variant of glucose (sugar) which makes up 1% of glucose in nature.

Official Title
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Preoperative Metabolomic Analysis of Primary Lung Cancer: A Translational Clinical Trial of the Brown Cancer Center

Conditions
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Carcinoma, Non-Small Cell Lung, Carcinoma, Small Cell Lung

Intervention / Treatment
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* Other: 13-C-glucose


Participation Criteria
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Eligibility Criteria
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Lung Cancer Patients (Groups 1 & 2) Inclusion Criteria: patients with suspected, clinically diagnosed, or histologically diagnosed lung cancer. Occasionally, other cancers (including metastatic cancers to the lung) may be resected for the study as negative controls for NSCLC, as warranted by the particulars of the case. patients must have general medical conditions to allow them to undergo surgical resection of their primary tumor Exclusion Criteria: history of diabetes for the experimental group (surgery + glucose); patients with a history of diabetes are allowed in the control group (surgery/no glucose) known hepatitis C or HIV (AIDS) Healthy Subjects (Group 3) Inclusion Criteria: at least 30 years of age preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment Exclusion Criteria: prior history of diagnosed lung cancer known hepatitis C or HIV (AIDS)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 (Experimental Group)<br>250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will receive 13-C-glucose prior to surgery | Other: 13-C-glucose<br>* 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.<br>|
| Group 2 (Control Group)<br>250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will not receive 13-C-glucose prior to surgery | |
| Group 3 (Healthy Subjects)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic profiles of cancerous vs. healthy lung tissue |  | after 13-C-glucose infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycolytic metabolism in plasma |  | before and after 13-C-glucose infusion | 
| metabolic markers in urine |  | collected during surgery | 
| metabolic markers in serum |  | before and after 13-C-glucose infusion | 
| metabolic markers in bronchoalveolar fluid |  | during diagnostic bronchoscopy or during surgery | 
| metabolic markers in expired breath |  | during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, non-small cell lung cancer, small cell lung cancer, cancer metabolism