A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer (EBUS)
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|ClinicalTrials.gov Identifier: NCT01409681|
Recruitment Status : Terminated (PI decided to terminate the study)
First Posted : August 4, 2011
Last Update Posted : March 31, 2014
|Condition or disease|
|Non-Small Cell Lung Cancer|
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.
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|Official Title:||A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||December 2013|
NSCLC subject undergoing bronchoscopy
- Time to lung cancer related death [ Time Frame: 18 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409681
|United States, Michigan|
|United States Department of Veteran's Affairs Medical Center|
|Ann Arbor, Michigan, United States, 48105|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Nithya Ramnath, MD||University of Michigan Medical Center and Veteran's Administration Health Center|