Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device - Full Text View

Purpose

This study is being done to see if the Nova Creatinine Meter can give a correct measure of creatinine (a blood test used to measure kidney function) when the blood is taken from a capillary (smallest type of blood vessels). The Nova Creatinine Meter is a hand held device that can be used in a clinic to measure creatinine in about 50 seconds. Current laboratory creatinine testing can take up to an hour. Since chemotherapy patients need to have their creatinine measured prior to treatment, this meter could make testing easier and faster.

Condition	Intervention
Cancer	Other: hand-held POC creatinine analyzer-blood test

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Heparin Creatinine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

The primary outcomes would be, reduced wait time and increased patient satisfaction. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

reduced blood loss [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

blood

Estimated Enrollment:	50
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts

Assigned Interventions

1

Patients receiving therapy for the treatment of their specific cancer.

Other: hand-held POC creatinine analyzer-blood test

This study will require the collection of a finger-puncture capillary blood specimen in addition to one green stoppered heparin containing collection tube. This is taken pre-therapy. The capillary whole blood specimen will be used to perform a creatinine determination on the "investigational" hand-held creatinine analyzer using special test strips for the analysis.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

MSKCC Clinics

Criteria

Inclusion Criteria:

Written Informed Consent
Must be having a CBC drawn
Must be having a Creatinine drawn

Exclusion Criteria:

Patients who are less than 18 years of age
Patients not having chemotherapy
Patients not having a CBC drawn

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607529

Contacts


Contact: Martin Fleisher, PhD		fleishem@mskcc.org

Contact: Manish Shah, MD		shah1@mskcc.org

Locations


United States, New York
	Memorial Sloan Kettering Cancer Center	Recruiting
	New York, New York, United States, 10065
	Contact: Martin Fleisher, PhD fleishem@mskcc.org
	Contact: Manish Shah, MD shah1@mskcc.org
	Principal Investigator: Martin Fleisher, PhD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Nova Biomedical Corporation

Investigators


Principal Investigator:	Martin Fleisher, PhD	Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Martin Fleisher, PhD )
Study ID Numbers:	07-023
First Received:	January 22, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00607529
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Multiple Diseases

Study placed in the following topic categories:

Heparin

Calcium heparin

ClinicalTrials.gov processed this record on August 21, 2008

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Nova Biomedical Corporation
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00607529