A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer (EBUS)
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.
Non-Small Cell Lung Cancer
|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|
- 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
|Study Start Date:||May 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
NSCLC subject undergoing bronchoscopy
This study seeks to prospectively determine the relationship between Vitamin D gene expression and median survival as a primary outcome, and the relationships 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.
Patients who are suspected to have lung cancer will be recruited to this study prior to their diagnostic biopsy. Those who have consented to the study will give permission for blood and tissue from this biopsy to be analyzed for the study endpoints. Statistical analysis on this data will seek to correlate CYP24A1 expression and medican survival of the participants. Patients' data will be collected for smoking status and cancer stage.
Study enrollment to adequately power the study statistically is 80 patients. Anticipated study duration is from 12 months to 18 months for sample collection and two years for follow-up for patient survival.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409681
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|United States Department of Veteran's Affairs Medical Center|
|Ann Arbor, Michigan, United States, 48105|
|Principal Investigator:||Nithya Ramnath, MD||University of Michigan Medical Center and Veteran's Administration Health Center|