Metabolomic Analysis of Lung Cancer

Completed

• Conditions: Carcinoma, Non-Small Cell Lung; Carcinoma, Small Cell Lung
• Interventions: Other: 13-C-glucose

• Registration Number: NCT00263731
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-07
• Study First Submitted QC: 2005-12-08
• Study First Posted: 2005-12-09
• Primary Completion: 2020-09-24
• Study Completion: 2020-09-24
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 (Experimental Group)	13-C-glucose	250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will receive 13-C-glucose prior to surgery

Primary Outcome Measures

Name	Time	Method
metabolic profiles of cancerous vs. healthy lung tissue	after 13-C-glucose infusion

Secondary Outcome Measures

Name	Time	Method
metabolic markers in expired breath	during surgery
glycolytic metabolism in plasma	before and after 13-C-glucose infusion
metabolic markers in urine	collected during surgery
metabolic markers in bronchoalveolar fluid	during diagnostic bronchoscopy or during surgery
metabolic markers in serum	before and after 13-C-glucose infusion

Trial Locations

Locations (1)

James Graham Brown Cancer Center, University of Louisville; 🇺🇸 Louisville, Kentucky, United States