- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00898027
Effect of Epidermal Growth Factor Receptor Inhibitors on Magnesium Homeostasis in Patients With Cancer
Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis
RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer receiving epidermal growth factor receptor inhibitors may help doctors understand the effect of epidermal growth factor receptor inhibitors on magnesium levels in the body.
PURPOSE: This laboratory study is looking at the effect of epidermal growth factor receptor inhibitors on magnesium homeostasis in patients with cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the effects of EGFR inhibitors on magnesium homeostasis in patients with cancer.
OUTLINE: This is a pilot study.
Patients undergo blood and urine sample collection at baseline and at 2, 4, and 8 weeks during treatment.
After finishing treatment, patients are followed periodically for up to 10 weeks.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Diagnosis of malignancy
- Planning to receive therapy with an inhibitor of the EGFR pathway (either on or off a clinical trial and may be monotherapy or combined with other therapies)
- Normal serum magnesium level
Exclusion Criteria:
- Glomerular filtration rate ≥ 60 mL/min
- No severe underlying renal dysfunction
- Normal serum potassium and calcium level
- No history of primary or secondary hyperparathyroidism
PRIOR CONCURRENT THERAPY:
- No prior EGFR pathway inhibitor
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effects of EGFR inhibitors on magnesium homeostasis
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
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
Other Study ID Numbers
- VICC GI 0615
- VU-VICC-GI-0615
- VU-VICC-IRB-060364
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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