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

This study has been terminated.
(Preliminary data did not show expected outcomes.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01063998
First Posted: February 5, 2010
Last Update Posted: November 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Jason Hafron, William Beaumont Hospitals
  Purpose
The ultimate goal of this project is to develop a simple non-invasive method to screen patients for potential kidney tumors.

Condition Intervention
Renal Cell Carcinoma Other: Urine Marker

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Urinary Tumor Marker (Kidney Injury Molecule-1) for the Detection of Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Jason Hafron, William Beaumont Hospitals:

Primary Outcome Measures:
  • To test the sensitivity and specificity of KIM-1 urine excretion in a group of patients with kidney cancer. [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
Renal tumor.

Enrollment: 23
Study Start Date: September 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients having nephrectomy.
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063998


Locations
United States, Michigan
Beaumont Hospitals
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Jason Hafron
William Beaumont Hospitals
Investigators
Principal Investigator: Jason Hafron, MD Beaumont Hospitals
  More Information

Responsible Party: Jason Hafron, Chairman, Dept of Urology, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01063998     History of Changes
Other Study ID Numbers: 2009-125
First Submitted: September 2, 2009
First Posted: February 5, 2010
Last Update Posted: November 8, 2013
Last Verified: November 2013

Keywords provided by Jason Hafron, William Beaumont Hospitals:
Renal cell
Carcinoma
Biomarkers

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases