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
  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:


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

Enrollment: 41
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational Group
NSCLC subject undergoing bronchoscopy

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
United States Department of Veteran's Affairs Medical Center
Ann Arbor, Michigan, United States, 48105
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: March 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014