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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational Group

NSCLC subject undergoing bronchoscopy

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nithya Ramnath, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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United States Department of Veteran's Affairs Medical Center

Ann Arbor, Michigan, United States

Site Status

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM 44333

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2010.105

Identifier Type: -

Identifier Source: org_study_id