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Clinical Trials/NCT01063998
NCT01063998
Terminated
Not Applicable

A Urinary Tumor Marker (Kidney Injury Molecule-1) for the Detection of Renal Cell Carcinoma

Jason Hafron1 site in 1 country23 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Cell Carcinoma
Sponsor
Jason Hafron
Enrollment
23
Locations
1
Primary Endpoint
To test the sensitivity and specificity of KIM-1 urine excretion in a group of patients with kidney cancer.
Status
Terminated
Last Updated
12 years ago

Overview

Brief Summary

The ultimate goal of this project is to develop a simple non-invasive method to screen patients for potential kidney tumors.

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
March 2012
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Jason Hafron
Responsible Party
Sponsor Investigator
Principal Investigator

Jason Hafron

Chairman, Dept of Urology

William Beaumont Hospitals

Eligibility Criteria

Inclusion Criteria

  • Patients demonstrate normal serum creatinine and no radiological evidence of a renal tumor.
  • Patients diagnosed with renal cancer and normal creatinine.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To test the sensitivity and specificity of KIM-1 urine excretion in a group of patients with kidney cancer.

Time Frame: 1 month

Study Sites (1)

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