Trials Sponsors Conditions Drugs Pricing

Conditions

Carcinoma, Non-Small Cell Lung Carcinoma, 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)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Sponsors & Collaborators

James Graham Brown Cancer Center
Othercollaborator
University of Louisville
Otherlead

Study Sites (1)

James Graham Brown Cancer Center, University of Louisville

Louisville, Kentucky, 40202, United States

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

Enrollment

249 participants (actual enrollment reported by the registry).

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 2005

Date type not reported

This date has not been verified as actual or estimated.

Metabolomic Analysis of Lung Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Group 1 (Experimental Group)

Group 2 (Control Group)

Group 3 (Healthy Subjects)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Group 1 (Experimental Group)

Group 2 (Control Group)

Group 3 (Healthy Subjects)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations