Metabolomic Analysis of Lung Cancer

This study is currently recruiting participants.
Verified March 2014 by James Graham Brown Cancer Center
Sponsor:
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: March 13, 2014
Last verified: March 2014

December 7, 2005
March 13, 2014
December 2005
December 2015   (final data collection date for primary outcome measure)
metabolic profiles of cancerous vs. healthy lung tissue [ Time Frame: after 13-C-glucose infusion ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00263731 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
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Metabolomic Analysis of Lung Cancer
Preoperative Metabolomic Analysis of Primary Lung Cancer: A Translational Clinical Trial of the Brown Cancer Center

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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
  • 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.
  • Carcinoma, Non-Small Cell Lung
  • Carcinoma, Small Cell Lung
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 1 (Experimental Group)
    250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will receive 13-C-glucose prior to surgery
    Intervention: Other: 13-C-glucose
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
December 2016
December 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
Yes
Contact: Clinical Trials Office, Brown Cancer Center 502-562-3429 ctobcc@louisville.edu
United States
 
NCT00263731
523.05, BCC-LUN-05-002
Yes
James Graham Brown Cancer Center
James Graham Brown Cancer Center
University of Louisville
Principal Investigator: Donald M Miller, MD, PhD James Graham Brown Cancer Center
James Graham Brown Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP