Diagnosis of MGRS in Patients With Paraproteinemias: Clinical, Anatomopathological and Pathophysiological Study (MGRS-CAPS)

February 23, 2019 updated by: MARIANA CIOCCHINI, Academia Nacional de Medicina

Diagnosis of Monoclonal Gammopathy of Renal Significance in Patients With Paraproteinemias

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425ASU
        • Recruiting
        • Academia Nacional de Medicina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hematological or nephrological patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academia Nacional de Medicina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2019

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

August 5, 2018

First Submitted That Met QC Criteria

August 12, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 23, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T.I. N° 12702/18/H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Monoclonal Gammopathy of Renal Significance

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe