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

NCT ID: NCT01063998

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Renal Cell Carcinoma

Keywords

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Renal cell Carcinoma Biomarkers

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients demonstrate normal serum creatinine and no radiological evidence of a renal tumor.

Urine Marker

Intervention Type OTHER

Urinary KIM-1 measurements

p 2

Patients diagnosed with renal cancer and normal creatinine.

Urine Marker

Intervention Type OTHER

Urinary KIM-1 measurements

Interventions

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Urine Marker

Urinary KIM-1 measurements

Intervention Type OTHER

Other Intervention Names

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Urine biomarkers KIM-1

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William Beaumont Hospitals

OTHER

Sponsor Role collaborator

Jason Hafron

OTHER

Sponsor Role lead

Responsible Party

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Jason Hafron

Chairman, Dept of Urology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jason Hafron, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospitals

Locations

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Beaumont Hospitals

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2009-125

Identifier Type: -

Identifier Source: org_study_id