CancerNCT00607529
Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device
An observational study of Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- hand-held POC creatinine analyzer-blood test
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MSKCC patients
Who may be able to join
- Written Informed Consent
- Must have a creatinine > or = to than 3.5 mg/dl
Who cannot join
- Patients who are less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Cancer
- Being tested
- hand-held POC creatinine analyzer-blood test
- Keywords
- Multiple Diseases
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients having a creatinine drawn Receives: Other: hand-held POC creatinine analyzer-blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes would be, reduced wait time and increased patient satisfaction.
Measured: conclusion of the study
Secondary outcomes (1)
reduced blood loss
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startAug 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Biomedical Corporation
- Investigators
- Martin Fleisher, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607529
- Sponsor's protocol ID
- 07-023
- Status last verified
- Jun 2010
- First submitted
- 22 Jan 2008
- Last updated
- 4 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device
- ClinicalTrials.gov ID
- NCT00607529
- Acronym / sponsor ID
- 07-023
- Conditions
- Cancer
- Keywords
- Multiple Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Nova Biomedical Corporation
- Study start
- Aug 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: hand-held POC creatinine analyzer-blood testPatients having a creatinine drawn |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC patients
Key inclusion criteria (2 listed)
- Written Informed Consent
- Must have a creatinine > or = to than 3.5 mg/dl
Key exclusion criteria (1 listed)
- Patients who are less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hand-held POC creatinine analyzer-blood testThis 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. | Other | 1 |
Primary outcome
The primary outcomes would be, reduced wait time and increased patient satisfaction.
Time frame: conclusion of the study
1 secondary outcome
reduced blood loss
Time frame: conclusion of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Fleisher, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcomes would be, reduced wait time and increased patient satisfaction. (time frame: conclusion of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2010.