- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409681
A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer (EBUS)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Cancer Center
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Ann Arbor, Michigan, United States, 48105
- United States Department of Veteran's Affairs Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Unstable cardiovascular disease or other systemic disease
- Mental incompetence/active psychiatric illness
- Medical contraindication for bronchoscopy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Observational Group
NSCLC subject undergoing bronchoscopy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to lung cancer related death
Time Frame: 18 months
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Time to lung cancer related death
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18 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Nithya Ramnath, MD, University of Michigan Medical Center and Veteran's Administration Health Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCC 2010.105
- HUM 44333 (Other Identifier: University of Michigan Health System IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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