NCT00607529

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 4, 2010

Status Verified

June 1, 2010

Enrollment Period

2.8 years

First QC Date

January 22, 2008

Last Update Submit

June 3, 2010

Conditions

Cancer

Keywords

Multiple Diseases

Outcome Measures

Primary Outcomes (1)

  • The primary outcomes would be, reduced wait time and increased patient satisfaction.

    conclusion of the study

Secondary Outcomes (1)

  • reduced blood loss

    conclusion of the study

Study Arms (1)

1

Patients having a creatinine drawn

Other: hand-held POC creatinine analyzer-blood test

Interventions

hand-held POC creatinine analyzer-blood testOTHER

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MSKCC patients

You may qualify if:

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

You may not qualify if:

  • Patients who are less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Martin Fleisher, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

August 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 4, 2010

Record last verified: 2010-06

Locations

US(1)