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

NCT01409681 | Terminated DMC

• 2 other identifiers: UMCC 2010.105HUM 44333
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time to lung cancer related death

  Time to lung cancer related death

  18 months

Study Arms (1)

Observational Group

NSCLC subject undergoing bronchoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Scheduled for diagnostic bronchoscopy for suspected advanced stage lung cancer by CT/PET scanning.
• Tumor or lymph node accessible by transbronchial needle aspiration.
• Age 18-80.
• 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.

You may not qualify if:

• Unstable cardiovascular disease or other systemic disease
• Mental incompetence/active psychiatric illness
• Medical contraindication for bronchoscopy

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (2)

United States Department of Veteran's Affairs Medical Center

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nithya Ramnath, MD

  University of Michigan Medical Center and Veteran's Administration Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: August 4, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 31, 2014

Record last verified: 2014-03

Locations

US (2)