Metabolomic Analysis of Lung Cancer

NCT ID: NCT00263731

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2020-09-24

Brief Summary

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

Detailed Description

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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.

Conditions

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Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 (Experimental Group)

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

13-C-glucose

Intervention Type OTHER

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

No interventions assigned to this group

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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


* at least 30 years of age
* preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment

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)


* prior history of diagnosed lung cancer
* known hepatitis C or HIV (AIDS)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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James Graham Brown Cancer Center

OTHER

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Donald Miller

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donald M Miller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center

Locations

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James Graham Brown Cancer Center, University of Louisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

Related Links

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http://www.browncancercenter.org

James Graham Brown Cancer Center

Other Identifiers

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BCC-LUN-05-002

Identifier Type: OTHER

Identifier Source: secondary_id

523.05

Identifier Type: -

Identifier Source: org_study_id

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