The Role of Microparticles as a Biomarker | NCT02626663

Studies
The Role of Microparticles as a Biomarker

NCT02626663

Sponsor

University of Rochester

Status

Withdrawn

Last Update Posted

Feb 19, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Atypical Hemolytic Uremic Syndrome
Thrombotic Thrombocytopenic Purpura
Microparticles
Microangiopathic Hemolytic Anemia

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left the University, sponsor pulled funding

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Oct 20, 2015

First Submission Date that Met QC Criteria

Dec 8, 2015

First Posted Date

Dec 10, 2015Estimated

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

Feb 15, 2019

Last Update Posted Date

Feb 19, 2019Actual

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

The investigators propose to characterize MPs in aHUS and TTP both at the onset and throughout treatment. The investigators believe that the number, size, and cell origin of MPs will differ between these two diseases. The hypothesis is that endothelial derived MPs will be higher in number and comprise a larger portion of the MP population in aHUS and that platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The investigators believe that MP identity and number can be used to reliably differentiate between aHUS and TTP at disease onset.

Detailed Description

Not provided

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

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aHUS		atypical Hemolytic Uremic Syndrome
TTP		Thrombotic thrombocytopenic purpura
MAHA		other microangiopathic hemolytic anemias

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microparticle/Nanoparticle number (an absolute number)		an average of 3 months
Microparticle/Nanoparticle size (in nanometers or micrometers)		an average of 3 months
Microparticle/Nanoparticle identity (identity of cell type from which they are derived)		an average of 3 months

Secondary Outcomes

Measure	Description	Time Frame
Morbidities		3 months
Mortality		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with MAHA, TTP, and/or aHUS

Exclusion Criteria:

Prisoners

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Patients presenting with Microangiopathic Hemolytic Anemias (MAHA), TTP, and/or aHUS are eligible.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amy Schmidt, MD PhD	University of Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester Medical Center		Rochester	New York		United States

Condition Browse Module

MeSH Terms

ID	Term
D065766	Atypical Hemolytic Uremic Syndrome
D011697	Purpura, Thrombotic Thrombocytopenic
D000743	Anemia, Hemolytic

Ancestor Terms

ID	Term
D006463	Hemolytic-Uremic Syndrome
D014511	Uremia
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided