A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/3/2014 |
| Start Date: | May 2011 |
| End Date: | July 2014 |
| Contact: | Nithya Ramnath, MD |
| Email: | canceranswerline@umich.edu |
| Phone: | 734/647-1417 |
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 (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.
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.
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
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2
sites
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