Clinical trial NCT01409681: A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer
Official title: A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with early-stage non-small cell lung cancer undergoing a broncoscopy at the University of Michigan Health Center or at the Ann Arbor Veteran's Administration Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to lung cancer related death
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: United States Department of Veteran's Affairs Medical Center
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Medical Center and Veteran's Administration Health Center
name: Nithya Ramnath, MD
role: PRINCIPAL_INVESTIGATOR
References: