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Preoperative Metabolomic Analysis of Primary Lung Cancer: A Translational Clinical Trial of the Brown Cancer Center


Phase 1
18 Years
75 Years
Open (Enrolling)
Both
Carcinoma, Non-Small Cell Lung, Carcinoma, Small Cell Lung

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Trial Information

Preoperative Metabolomic Analysis of Primary Lung Cancer: A Translational Clinical Trial of the Brown Cancer Center


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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

metabolic profiles of cancerous vs. healthy lung tissue

Outcome Time Frame:

after 13-C-glucose infusion

Safety Issue:

No

Principal Investigator

Donald M Miller, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

523.05

NCT ID:

NCT00263731

Start Date:

December 2005

Completion Date:

December 2014

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • Carcinoma, Small Cell Lung
  • lung cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • cancer metabolism
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell

Name

Location

James Graham Brown Cancer Center, University of LouisvilleLouisville, Kentucky  40202