Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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