Clinical trial NCT00263731: Metabolomic Analysis of Lung Cancer
Official title: Preoperative Metabolomic Analysis of Primary Lung Cancer: A Translational Clinical Trial of the Brown Cancer Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small Cell Lung
Carcinoma, Small Cell Lung
Keywords: lung cancer
non-small cell lung cancer
small cell lung cancer
cancer metabolism
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2005-12-09
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

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 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)

Primary outcomes:
measure: metabolic profiles of cancerous vs. healthy lung tissue
timeFrame: after 13-C-glucose infusion
Secondary outcomes:
measure: glycolytic metabolism in plasma
timeFrame: before and after 13-C-glucose infusion
measure: metabolic markers in urine
timeFrame: collected during surgery
measure: metabolic markers in serum
timeFrame: before and after 13-C-glucose infusion
measure: metabolic markers in bronchoalveolar fluid
timeFrame: during diagnostic bronchoscopy or during surgery
measure: metabolic markers in expired breath
timeFrame: during surgery
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center, University of Louisville
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center
name: Donald M Miller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: