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:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Jason Hafron, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01063998
First received: September 2, 2009
Last updated: November 6, 2013
Last verified: November 2013
  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 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jason Hafron, Chairman, Dept of Urology, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01063998     History of Changes
Other Study ID Numbers: 2009-125
Study First Received: September 2, 2009
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Renal cell
Carcinoma
Biomarkers

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

ClinicalTrials.gov processed this record on October 29, 2014