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

November 6, 2013 updated by: Jason Hafron
The ultimate goal of this project is to develop a simple non-invasive method to screen patients for potential kidney tumors.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients having nephrectomy.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: Urine Marker
Urinary KIM-1 measurements
Other Names:
  • Urine biomarkers
  • KIM-1
p 2
Patients diagnosed with renal cancer and normal creatinine.
Other: Urine Marker
Urinary KIM-1 measurements
Other Names:
  • Urine biomarkers
  • KIM-1

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

This is where you will find people and organizations involved with this study.

Sponsor

Jason Hafron

Collaborators

William Beaumont Hospitals

Investigators

  • Principal Investigator: Jason Hafron, MD, Beaumont Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 6, 2013

Last Verified

November 1, 2013

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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