Clinical trial NCT03629561: Diagnosis of MGRS in Patients With Paraproteinemias: Clinical, Anatomopathological and Pathophysiological Study
Official title: Diagnosis of Monoclonal Gammopathy of Renal Significance in Patients With Paraproteinemias
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Monoclonal Gammopathy of Renal Significance
Keywords: "Paraproteinemias"[Mesh]
"Kidney Diseases"[Mesh]
Lead sponsor: Academia Nacional de Medicina
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hematological or nephrological patients

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.


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.

Primary outcomes:
measure: Renal histopathology compatible with MGRS
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Renal physiopathological changes
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Academia Nacional de Medicina
Study officials:
References:
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