Diagnosis of MGRS in Patients With Paraproteinemias: Clin... | NCT03629561

Studies
Diagnosis of MGRS in Patients With Paraproteinemias: Clinical, Anatomopathological and Pathophysiological Study

NCT03629561

Sponsor

Academia Nacional de Medicina

Status

Unknown status

Last Update Posted

Feb 26, 2019Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Monoclonal Gammopathy of Renal Significance

Interventions

Not provided

Countries

Argentina

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

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 23, 2019Actual

Primary Completion Date

Nov 2020Estimated

Completion Date

Feb 2021Estimated

First Submitted Date

Aug 5, 2018

First Submission Date that Met QC Criteria

Aug 12, 2018

First Posted Date

Aug 14, 2018Actual

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 23, 2019

Last Update Posted Date

Feb 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

MARIANA CIOCCHINI, Principal Investigator, Academia Nacional de MedicinaPrincipal Investigator

Lead Sponsor

Academia Nacional de MedicinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This is the first prospective study which evaluate patients with small B-cell clones to diagnose monoclonal gammopathy of renal significance (MGRS) and characterize it clinically, anatomopathologically and pathophysiologically taking int account a geriatric approach.

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

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal histopathology compatible with MGRS		through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
Renal physiopathological changes		through study completion, an average of 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Paraproteinemias

Exclusion Criteria:

Multiple Myeloma
Waldenstrom Macroglobulinemia
Chronic Lymphocytic Leukemia
Malignant Lymphoma
Monoclonal gammopathy of unknown significance (MGUS) secondary to Infections
MGUS secondary to Autoimmune Diseases
Uncompleted hematological evaluation
Renal tumor except for cysts Bosniak type I/II
Other malignant neoplasia
Unresolved obstructive uropathy
Patients with only one kidney except for renal transplant
Co-morbidities which would limit the ability to receive aggressive therapeutic intervention
Fragile old people
Pregnancy
Prison
Impatient in psychiatric institutions.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Hematological or nephrological patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mariana Ciocchini, Nephrologist	Contact	+54 9 11 6172 2738		marianaciocchini@pm.me

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academia Nacional de Medicina	Recruiting	Buenos Aires		1425ASU	Argentina

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28425076	Background	Ciocchini M, Arbelbide J, Musso CG. Monoclonal gammopathy of renal significance (MGRS): the characteristics and significance of a new meta-entity. Int Urol Nephrol. 2017 Dec;49(12):2171-2175. doi: 10.1007/s11255-017-1594-y. Epub 2017 Apr 19.
29134615	Background	Ciocchini M, Musso CG. What is the place of POEMS syndrome in the current classification of monoclonal gammopathies of renal significance? Int Urol Nephrol. 2018 Feb;50(2):383-384. doi: 10.1007/s11255-017-1739-z. Epub 2017 Nov 13. No abstract available.