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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01063998
Other study ID # 2009-125
Secondary ID
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


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
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