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Completed

NCT Number: NCT00263731

Metabolomic Analysis of Lung Cancer

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

James Graham Brown Cancer Center, University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

13-C-glucose

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.

Primary outcomes

  1. metabolic profiles of cancerous vs. healthy lung tissue

    Time frame: after 13-C-glucose infusion

Secondary outcomes

  1. glycolytic metabolism in plasma

    Time frame: before and after 13-C-glucose infusion

  2. metabolic markers in urine

    Time frame: collected during surgery

  3. metabolic markers in serum

    Time frame: before and after 13-C-glucose infusion

  4. metabolic markers in bronchoalveolar fluid

    Time frame: during diagnostic bronchoscopy or during surgery

  5. metabolic markers in expired breath

    Time frame: during surgery

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • James Graham Brown Cancer Center

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2020
Study completion
2020
First posted
Dec 9, 2005
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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