Metabolomic Analysis of Lung Cancer

Carcinoma, Non-Small Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263731
• Other study ID #: 523.05
• Secondary ID: BCC-LUN-05-002
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Small Cell
• Carcinoma, Small Cell Lung
• Lung Neoplasms
• Small Cell Lung Carcinoma

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

External Links

•   James Graham Brown Cancer Center