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

This study is currently recruiting participants.

Verified by Memorial Sloan-Kettering Cancer Center, March 2009

First Received: January 22, 2008 Last Updated: March 27, 2009 History of Changes

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

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

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Creatinine

U.S. FDA Resources

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 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients having a creatinine drawn	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.

Groups/Cohorts

Assigned Interventions

Patients having a creatinine drawn

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 patients

Criteria

Inclusion Criteria:

Written Informed Consent
Must have a creatinine > or = to than 3.5 mg/dl

Exclusion Criteria:

Patients who are less than 18 years of age

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

Additional Information:

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

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Martin Fleisher, PhD )
Study ID Numbers:	07-023
Study First Received:	January 22, 2008
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00607529 History of Changes
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 September 03, 2009