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Metabolomic Analysis of Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 29, 2014
Last verified: September 2014
  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 2016
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 29, 2014
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
Carcinoma, Small Cell
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014