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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01063998
• Other study ID #: 2009-125
• Status: Terminated
• Phase: N/A
• First received: September 2, 2009
• Last updated: November 6, 2013
• Start date: September 2009
• Est. completion date: March 2012

Study information

• Verified date: November 2013
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Other:
• Urine Marker
Urinary KIM-1 measurements

Locations

Country	Name	City	State
United States	Beaumont Hospitals	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Jason Hafron	William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the sensitivity and specificity of KIM-1 urine excretion in a group of patients with kidney cancer.		1 month	No