Metabolomic Analysis of Lung Cancer

University of Louisville (UOFL)

Status: Completed

Conditions: Carcinoma, Non-Small Cell Lung; Carcinoma, Small Cell Lung

Treatments: Other: 13-C-glucose

Study type: Observational

Funder types: Other

Identifiers

NCT00263731

BCC-LUN-05-002 (Other Identifier)

523.05

Details and patient eligibility

About

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

Full 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.

Enrollment: 249 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

249 participants in 3 patient groups

Group 1 (Experimental Group)

Description:

250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will receive 13-C-glucose prior to surgery

Treatment:

Other: 13-C-glucose

Group 2 (Control Group)

Description:

250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will not receive 13-C-glucose prior to surgery

Group 3 (Healthy Subjects)

Description:

250 healthy subjects (must be at least 30 years of age and have no prior history of diagnosed lung cancer) will provide 1 blood sample and 1 urine sample.