A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified on August 2011 by University of Michigan Cancer Center

First Received on July 22, 2011.  
Last Updated on August 16, 2011  
History of Changes
This Clinical Trial Sponsored By: University of Michigan Cancer Center
Information provided by: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01409681
 

Purpose for Clinical Trial

Vitamin D exerts antiproliferative and differentiating effects in cancers, including non-small cell lung cancer (NSCLC). The active form of Vitamin D is 1,25, dihydroxycholecalciferol (calcitriol) which rapidly induces expression of cytochrome P450 24R-hydroxylase (CYP24A1). CYP24A1 initiates inactivation of calcitriol as a result of successive hydroxylation/oxidation reactions. This study seeks to prospectively determine the relationship between Vitamin D gene expression and median survival as a primary outcome, and between the Vitamin D receptor (VDR)/CYP24A1 gene expression and cancer stage, smoking status, serum 1,25 (OH)2D3 levels as well as CYP24A1 genotype.

Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Lung Cancer
Vitamin D
Drug Information available for:
Vitamin D

U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures For Clinical Trial:

  • Time to lung cancer related death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Time to lung cancer related death

Biospecimen Retention:   Samples With DNA

Bronchial brush samples Bronchoscopy samples for RNA extraction and RT-PCR expression Blood samples

  • 7 mL for measurement of Serum total Vit-D levels and 1,25 (OH)2 D3 levels;
  • 5 ml collected in EDTA tube for CYP24A1 genotype analysis (common metabolizing agent for calcitriol) and CYP24 polymorphisms analysis

Estimated Enrollment: 80
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts

Observational Group

NSCLC subject undergoing bronchoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with early-stage non-small cell lung cancer undergoing a broncoscopy at the University of Michigan Health Center or at the Ann Arbor Veteran’s Administration Hospital

Criteria

Inclusion Criteria:

  1. Scheduled for diagnostic bronchoscopy for suspected advanced stage lung cancer by CT/PET scanning.
  2. Tumor or lymph node accessible by transbronchial needle aspiration.
  3. Age 18-80.
  4. All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

  1. Unstable cardiovascular disease or other systemic disease
  2. Mental incompetence/active psychiatric illness
  3. Medical contraindication for bronchoscopy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409681

Contacts
Contact: Cancer AnswerLine 800-865-1125 canceranswerline@umich.edu

Locations
United States, Michigan
University of Michigan Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Julie Balk     734-615-2109     jhossler@med.umich.edu    
Contact: Julie Trzeciak     734-232-0798     juliefor@med.umich.edu    
Principal Investigator: Nithya Ramnath, MD            
Sub-Investigator: Paul Christensen, MD            
Sub-Investigator: Kristy Bauman, MD            
Sub-Investigator: Douglas Arenberg, MD            
Sub-Investigator: Gregory Kalemkerian, MD            
Sub-Investigator: Jeffrey Horowitz, MD            
Sub-Investigator: Anthony Courey, MD            
Sub-Investigator: Khaled Hassan, MD            
Sub-Investigator: David Beer, MD            
Sub-Investigator: Lili Zhao, Ph.D.            
Sub-Investigator: Julie Balk, BS, CCRP            
United States Department of Veteran’s Affairs Medical Center Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Julie Balk     734-615-3137     jhossler@med.umich.edu    
Contact: Julie Trzeciak     734-232-0798     juliefor@med.umich.edu    
Principal Investigator: Nithya Ramnath, MD            
Sub-Investigator: Paul Christensen, MD            

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