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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00263731
Other study ID # 523.05
Secondary ID BCC-LUN-05-002
Status Completed
Phase
First received
Last updated
Start date December 2005
Est. completion date September 24, 2020

Study information

Verified date May 2022
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 249
Est. completion date September 24, 2020
Est. primary completion date September 24, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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)

Study Design


Intervention

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.

Locations

Country Name City State
United States James Graham Brown Cancer Center, University of Louisville Louisville Kentucky

Sponsors (2)

Lead Sponsor Collaborator
University of Louisville James Graham Brown Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary metabolic profiles of cancerous vs. healthy lung tissue after 13-C-glucose infusion
Secondary glycolytic metabolism in plasma before and after 13-C-glucose infusion
Secondary metabolic markers in urine collected during surgery
Secondary metabolic markers in serum before and after 13-C-glucose infusion
Secondary metabolic markers in bronchoalveolar fluid during diagnostic bronchoscopy or during surgery
Secondary metabolic markers in expired breath during surgery
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