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Metabolomic Analysis of Lung Cancer
This study is currently recruiting participants.
Verified by James Graham Brown Cancer Center, May 2008
Sponsors and Collaborators: James Graham Brown Cancer Center
University of Louisville
Information provided by: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00263731
  Purpose

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
Carcinoma, Non-Small Cell Lung
Carcinoma, Small Cell Lung
Other: 13-C-glucose
Phase I

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Dextrose
U.S. FDA Resources
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

Further study details as provided by James Graham Brown Cancer Center:

Biospecimen Retention:   None Retained

Biospecimen Description:

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
1
Experimental Group: 27 subjects with NSCLC undergoing surgical resection, will receive glucose prior to surgery
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.
2
Control Group: 27 subjects with NSCLC undergoing surgical resection, will not receive glucose prior to surgery
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.

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 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.

  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): 27 lung cancer patients undergoing surgery, with 13C-glucose infusion);
  • Group 2 (control group): 27 lung cancer patients undergoing surgery, without 13C-glucose infusion); and
  • Group 3 (healthy [non-cancer] control subjects).
Criteria

Inclusion Criteria:

  • clinical diagnosis of resectable lung cancer (non-small cell or small cell)
  • healthy non-smoking volunteers

Exclusion Criteria:

  • diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263731

Contacts
Contact: Jamie M Day, BSN 502-562-3429 jmluka01@louisville.edu
Contact: Kate K Rodger, MSHCM, BSN (502) 562-3429 kkrodg01@louisville.edu

Locations
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            
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

James Graham Brown Cancer Center  This link exits the ClinicalTrials.gov site

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

Keywords provided by James Graham Brown Cancer Center:
lung cancer
non-small cell lung cancer
small cell lung cancer
cancer metabolism

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 16, 2009