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

Terminated

• Conditions: Renal Cell Carcinoma
• Interventions: Other: Urine Marker

• Registration Number: NCT01063998
• Lead Sponsor: Jason Hafron

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-06
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Urine Marker	Patients demonstrate normal serum creatinine and no radiological evidence of a renal tumor.
p 2	Urine Marker	Patients diagnosed with renal cancer and normal creatinine.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Beaumont Hospitals; 🇺🇸 Royal Oak, Michigan, United States