Multiple MyelomaNCT02035189
Observational Study Evaluating the Potential Impact of Procalcitonin Testing on Care of Stemcell Transplant Recipients
An observational study of Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
An observational study in evaluating the clinical impact of procalcitonin on the care of Stem cell transplant recipient and its performance as an adjunct in the diagnosis and prognostication of Infectious processes Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Multiple Myeloma
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Sep 2014
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Multiple Myeloma at UAMS receiving Stem Cell transplantation
Who may be able to join
- Patients age 18-95 years with Multiple Myeloma (MM) undergoing stem cell transplantation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Observational Study Evaluating the Potential Impact of Procalcitonin Testing on Care of Stemcell Transplant Recipients and Its Performance as an Adjunct in the Diagnosis and Prognostication of Infectious Processes
An observational study in evaluating the clinical impact of procalcitonin on the care of Stem cell transplant recipient and its performance as an adjunct in the diagnosis and prognostication of Infectious processes
Read the detailed description
The overall goal of this project will be to provide new insights into the use of biomarkers in surveillance for infectious processes in Stem Cell Transplant recipients by evaluating the added impact of procalcitonin testing on detection of infectious processes
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Procalcitonin
Levels of Procalcitonin will be measured daily for a period not to exceed 30 days.
Measured: Daily up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Senu Apewokin, MD, Principal investigator, University of ArkansasNaveen Sanathkumar, MD, Study director, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035189
- Sponsor's protocol ID
- 202342
- Status last verified
- Mar 2015
- First submitted
- 9 Jan 2014
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating the Potential Impact of Procalcitonin Testing on Care of Stemcell Transplant Recipients and Its Performance as an Adjunct in the Diagnosis and Prognostication of Infectious Processes
- ClinicalTrials.gov ID
- NCT02035189
- Acronym / sponsor ID
- 202342
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Jan 2014 (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.
An observational study in evaluating the clinical impact of procalcitonin on the care of Stem cell transplant recipient and its performance as an adjunct in the diagnosis and prognostication of Infectious processes
Detailed description
The overall goal of this project will be to provide new insights into the use of biomarkers in surveillance for infectious processes in Stem Cell Transplant recipients by evaluating the added impact of procalcitonin testing on detection of infectious processes
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Multiple Myeloma at UAMS receiving Stem Cell transplantation
Key inclusion criteria (1 listed)
- Patients age 18-95 years with Multiple Myeloma (MM) undergoing stem cell transplantation
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels of Procalcitonin
Time frame: Daily up to 30 days
Levels of Procalcitonin will be measured daily for a period not to exceed 30 days.
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 3 Mar 2015.
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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.
Senu Apewokin, MD principal investigator
University of Arkansas
Naveen Sanathkumar, MD study director
University of Arkansas
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 Multiple Myeloma, run by University of Arkansas 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 1 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 3 Mar 2015. 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?
Levels of Procalcitonin (time frame: Daily up to 30 days). 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 3 Mar 2015.