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

This study has been terminated.
(PI decided to terminate the study)
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01409681
First received: July 22, 2011
Last updated: March 28, 2014
Last verified: March 2014

July 22, 2011
March 28, 2014
May 2011
June 2013   (final data collection date for primary outcome measure)
Time to lung cancer related death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Time to lung cancer related death
Same as current
Complete list of historical versions of study NCT01409681 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer
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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Non-Probability Sample

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

Non-Small Cell Lung Cancer
Not Provided
Observational Group
NSCLC subject undergoing bronchoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
41
December 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01409681
UMCC 2010.105, HUM 44333
Yes
University of Michigan Cancer Center
University of Michigan Cancer Center
Not Provided
Principal Investigator: Nithya Ramnath, MD University of Michigan Medical Center and Veteran's Administration Health Center
University of Michigan Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP