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

Terminated

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT01409681
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-04
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-28
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to lung cancer related death	18 months	Time to lung cancer related death

Trial Locations

Locations (2)

United States Department of Veteran's Affairs Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

University of Michigan Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States