Text Size
Trial record 14 of 314 for:    cardiac CT OR CAT scan OR coronary artery scan | Open Studies | NIH, U.S. Fed
Previous Study | Return to List | Next Study

Pioglitazone for Lung Cancer Chemoprevention

This study is currently recruiting participants.
Verified January 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00780234
First received: October 24, 2008
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest CAT scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. $150 will be provided to the subject after completing the trial.


Condition Intervention Phase
Lung Cancer
Endobronchial Dysplasia
 Procedure: fluorescence bronchoscopy
Procedure: quantitative high resolution CT scan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pioglitazone for Lung Cancer Chemoprevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Changes in endobronchial histology [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 391
Study Start Date: August 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Current or former smokers receive 6 months of treatment with pioglitazone
 Procedure: fluorescence bronchoscopy
examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.
Procedure: quantitative high resolution CT scan
High resolution CT scan of the chest
Placebo Comparator: Arm 2
Current or former smokers receive 6 months of treatment with placebo
 Procedure: fluorescence bronchoscopy
examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.
Procedure: quantitative high resolution CT scan
High resolution CT scan of the chest

Detailed Description:

This trial evaluates the oral PPAR gamma agonist pioglitazone in a double-blind placebo controlled trial. The high risk current and former smokers qualify based on tobacco exposure, airflow limitation on lung function testing, and sputum cytologic atypia. Subjects have a quantitative high resolution thoracic CT scan and a fluorescent bronchoscopy at study entry and after 6 months on drug or placebo. Biologic samples are collected at both time points. The primary outcome is endobronchial histology and determining if pioglitazone can retard progression. Secondary endpoints related to the PPAR gamma signaling pathway will also be analyzed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current or former smoker (at least 10 pack years);
  • One or more of the following:
  • Mild or worse sputum atypia
  • Airflow Limitation (FEV1/FVC<70% predicted)
  • Biopsy proven airway dysplasia

Exclusion Criteria:

  • MI with ejection fraction < 50%;
  • severe/unstable angina;
  • history of coronary or peripheral arterial bypass grafting;
  • NYHA class III or IV congestive heart failure;
  • hypoxemia (less than POX 90 with supplemental oxygen); Diabetes type I or II; severe COPD (GOLD stage III or IV); clinically significant edema requiring diuretic therapy;
  • life expectancy < 6 months; history of bladder cancer
  • pregnant or breast feeding; inability to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780234

Contacts
Contact: Mary K Jackson (303) 724-1650 mary.k.jackson@ucdenver.edu
Contact: Brandi Bagwell (303) 724-1654 brandi.bagwell@ucdenver.edu

Locations
United States, Colorado
VA Eastern Colorado Health Care System, Denver Recruiting
Denver, Colorado, United States, 80220
Contact: Robert L Keith, MD     303-399-8020 ext 3182     robert.keith@va.gov    
Contact: York E Miller, MD     (303) 393-2869     york.miller@ucdenver.edu    
Principal Investigator: Robert L. Keith, MD            
United States, Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Recruiting
Nashville, Tennessee, United States, 37212-2637
Contact: Rena Burns, RN     615-873-7658     rena.burns@va.gov    
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Robert L. Keith, MD VA Eastern Colorado Health Care System, Denver
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00780234     History of Changes
Other Study ID Numbers: CLIN-005-08S
Study First Received: October 24, 2008
Last Updated: January 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
chemoprevention
lung cancer
pioglitazone

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013