- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01063998
A Urinary Tumor Marker (Kidney Injury Molecule-1) for the Detection of Renal Cell Carcinoma
Study Overview
Detailed Description
In the United States there were 38,900 cases and 12,840 deaths from renal cell carcinoma in 2006. Renal cell carcinoma represents 2% of all cancers worldwide. The majority of kidney tumors are discovered incidentally during investigation of unrelated complaints. However, nearly 30% of patients present with metastatic disease at the time of diagnosis and 30-40% of patients with clinically localized kidney cancer will have a recurrence. The diagnosis and monitoring of kidney cancer requires expensive and frequent imaging examinations. There is a significant need to find diagnostic and prognostic biomarkers to screen, diagnose, and monitor renal cancers.
A reliable urinary assay for kidney cancer would have major implications for tumor screening in high risk patients, in selection of patients for adjuvant therapy, in surveillance and prognosis and possibly as a surrogate marker for response to therapy. Human kidney injury molecule-1 (KIM-1) has been found to be a sensitive and specific biomarker in identifying kidney injury. The urine levels of KIM-1 are increased in the patients with kidney failure and major types of kidney tumors. The purpose of the study is investigate how urine KIM-1 and a routine blood marker for renal failure (creatinine) can distinguish kidney tumors from non-tumor kidney injury. The ultimate goal of this project is to develop a simple non-invasive method to screen patients for potential kidney tumors.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Royal Oak, Michigan, United States, 48073
- Beaumont Hospitals
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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:
- Patients demonstrate normal serum creatinine and no radiological evidence of a renal tumor.
OR
- Patients diagnosed with renal cancer and normal creatinine.
Exclusion Criteria:
- None.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Patients demonstrate normal serum creatinine and no radiological evidence of a renal tumor.
|
Urinary KIM-1 measurements
Other Names:
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p 2
Patients diagnosed with renal cancer and normal creatinine.
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Urinary KIM-1 measurements
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To test the sensitivity and specificity of KIM-1 urine excretion in a group of patients with kidney cancer.
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jason Hafron, MD, Beaumont Hospitals
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-125
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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