Metabolomic Analysis of Lung Cancer
This study is currently recruiting participants.
Verified January 2013 by James Graham Brown Cancer Center
Sponsor:
James Graham Brown Cancer Center
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00263731
First received: December 7, 2005
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to learn more about the metabolic properties of lung cancer cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung |
Other: 13-C-glucose |
Phase 1 |
| Study Type: | Observational |
| 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 |
Resource links provided by NLM:
Further study details as provided by James Graham Brown Cancer Center:
Primary Outcome Measures:
- metabolic profiles of cancerous vs. healthy lung tissue [ Time Frame: after 13-C-glucose infusion ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 750 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group 1 (Experimental Group)
250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will receive 13-C-glucose prior to surgery
|
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.
|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
- Group 1 (experimental group): 250 lung cancer patients undergoing surgery, with 13-C-glucose infusion);
- Group 2 (control group): 250 lung cancer patients undergoing surgery, without 13-C-glucose infusion); and
- Group 3 (healthy subjects): 250 subjects to provide 1 blood sample and 1 urine sample.
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263731
Contacts
| Contact: Clinical Trials Office, Brown Cancer Center | 502-562-3429 | ctobcc@louisville.edu |
Locations
| United States, Kentucky | |
| James Graham Brown Cancer Center, University of Louisville | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Principal Investigator: Donald M Miller, MD, PhD | |
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
| Principal Investigator: | Donald M Miller, MD, PhD | James Graham Brown Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | James Graham Brown Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00263731 History of Changes |
| Other Study ID Numbers: | 523.05, BCC-LUN-05-002 |
| Study First Received: | December 7, 2005 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by James Graham Brown Cancer Center:
|
lung cancer non-small cell lung cancer small cell lung cancer cancer metabolism |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Small Cell Lung Carcinoma Carcinoma, Small Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013