Metabolomic Analysis of Lung Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small Cell Lung; Carcinoma, Small Cell Lung
• Intervention / Treatment: Other: 13-C-glucose

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 Type: Observational
• Enrollment (Actual): 249

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center, University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Group 1 (experimental group): 250 lung cancer patients undergoing surgery, with 13-C-glucose infusion);
• Group 2 (control group): 250 lung cancer patients undergoing surgery, without 13-C-glucose infusion); and
• Group 3 (healthy subjects): 250 subjects to provide 1 blood sample and 1 urine sample.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (Experimental Group); 250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will receive 13-C-glucose prior to surgery	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.
Group 2 (Control Group); 250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will not receive 13-C-glucose prior to surgery
Group 3 (Healthy Subjects); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
metabolic profiles of cancerous vs. healthy lung tissue	after 13-C-glucose infusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: James Graham Brown Cancer Center
• Investigators: Principal Investigator: Donald M Miller, MD, PhD, James Graham Brown Cancer Center

Publications and helpful links

Helpful Links

• James Graham Brown Cancer Center

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): September 24, 2020
• Study Completion (Actual): September 24, 2020

Study Registration Dates

• First Submitted: December 7, 2005
• First Submitted That Met QC Criteria: December 8, 2005
• First Posted (Estimate): December 9, 2005

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer; non-small cell lung cancer; small cell lung cancer; cancer metabolism
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Small Cell Lung Carcinoma; Carcinoma, Small Cell
• Other Study ID Numbers: 523.05; BCC-LUN-05-002 (Other Identifier: James Graham Brown Cancer Center Clinical Trials Office)