NCT00263731

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2005

Completed
14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2020

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

14.8 years

First QC Date

December 7, 2005

Last Update Submit

May 6, 2022

Conditions

Carcinoma, Non-Small Cell LungCarcinoma, Small Cell Lung

Keywords

lung cancernon-small cell lung cancersmall cell lung cancercancer metabolism

Outcome Measures

Primary Outcomes (1)

  • metabolic profiles of cancerous vs. healthy lung tissue

    after 13-C-glucose infusion

Secondary Outcomes (5)

  • 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

Study Arms (3)

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

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.

Interventions

13-C-glucoseOTHER

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 1 (Experimental Group)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • at least 30 years of age
  • preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment
  • prior history of diagnosed lung cancer
  • known hepatitis C or HIV (AIDS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Graham Brown Cancer Center, University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaLung Neoplasms

Interventions

1,2-O-isopropylidene-D-glucofuranose

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Donald M Miller, MD, PhD

    James Graham Brown Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 7, 2005

First Posted

December 9, 2005

Study Start

December 1, 2005

Primary Completion

September 24, 2020

Study Completion

September 24, 2020

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations

US(1)