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

This study is currently recruiting participants.
Verified February 2013 by University of Michigan Cancer Center
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01409681
First received: July 22, 2011
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Time to lung cancer related death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 80
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational Group
NSCLC subject undergoing bronchoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409681

Contacts
Contact: Cancer AnswerLine 800-865-1125 canceranswerline@umich.edu

Locations
United States, Michigan
University of Michigan Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nahid Hemati-Schraut     734-615-3137     nhemati@umich.edu    
Contact: Julie Trzeciak     734-232-0798     juliefor@med.umich.edu    
Principal Investigator: Nithya Ramnath, MD            
Sub-Investigator: Paul Christensen, MD            
Sub-Investigator: Kristy Bauman, MD            
Sub-Investigator: Douglas Arenberg, MD            
Sub-Investigator: Gregory Kalemkerian, MD            
Sub-Investigator: Jeffrey Horowitz, MD            
Sub-Investigator: Anthony Courey, MD            
Sub-Investigator: Khaled Hassan, MD            
Sub-Investigator: David Beer, MD            
Sub-Investigator: Lili Zhao, Ph.D.            
United States Department of Veteran's Affairs Medical Center Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Julie Balk     734-615-3137     jhossler@med.umich.edu    
Contact: Julie Trzeciak     734-232-0798     juliefor@med.umich.edu    
Principal Investigator: Nithya Ramnath, MD            
Sub-Investigator: Paul Christensen, MD            
Sub-Investigator: Kristy Bauman, MD            
Sub-Investigator: Julie Balk, BS, CCRP            
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Nithya Ramnath, MD University of Michigan Medical Center and Veteran's Administration Health Center
  More Information

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01409681     History of Changes
Other Study ID Numbers: UMCC 2010.105, HUM 44333
Study First Received: July 22, 2011
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013