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


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18 Years
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Open (Enrolling by invite only)
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Renal Cell Carcinoma

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Joseph Mashni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beaumont Hospitals

Authority:

United States: Institutional Review Board

Study ID:

2009-125

NCT ID:

NCT01063998

Start Date:

September 2009

Completion Date:

December 2012

Related Keywords:

  • Renal Cell Carcinoma
  • Renal cell
  • Carcinoma
  • Biomarkers
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Beaumont HospitalsRoyal Oak, Michigan  48073