Observational Study Evaluating the Potential Impact of Pr... | NCT02035189

Studies
Observational Study Evaluating the Potential Impact of Procalcitonin Testing on Care of Stemcell Transplant Recipients

NCT02035189

Sponsor

University of Arkansas

Status

Completed

Last Update Posted

Mar 3, 2015Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Jan 9, 2014

First Submission Date that Met QC Criteria

Jan 10, 2014

First Posted Date

Jan 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2015

Last Update Posted Date

Mar 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Levels of Procalcitonin	Levels of Procalcitonin will be measured daily for a period not to exceed 30 days.	Daily up to 30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients age 18-95 years with Multiple Myeloma (MM) undergoing stem cell transplantation

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Multiple Myeloma at UAMS receiving Stem Cell transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Senu Apewokin, MD	University of Arkansas	Principal Investigator
Naveen Sanathkumar, MD	University of Arkansas	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences		Little Rock	Arkansas	72205	United States

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided