Precision Medicine in LN: A Multicenter Proof-of-concept Study for Histopathological Biomarkers Analysis in Renal Biopsy

Launched by FUNDACIN BIOMEDICA GALICIA SUR · Apr 28, 2022

Keywords

ClinConnect Summary

Sample size For this proof-of-concept study, our objective is to analyze around 60 renal biopsy samples (expandable according to the results obtained).

Methods:

The following general variables will be collected:

* demographic data: age, sex, ethnicity.
* clinical data on SLE:
* diagnosis and chronological data: time of SLE diagnosis, time of LN diagnosis, time form SLE diagnosis to LN.
* 1997 ACR SLE classification criteria,
* activity: involvement of different organs and systems by SELENA-SLEDAI at the time of LN diagnosis and at the time of the last evaluation of the patient (or death,...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with a diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) criteria.
• • Diagnosis of lupus nephritis type 3,4,5 or mixed forms of the above according to the International Society of Nephrology (ISN)/Renal Pathology Society (RPS) classification of LN.
• • Date of performance of the renal biopsy: year 2000 or later. The reason for this time frame is the theoretical homogenization in the therapeutic management of LN with the introduction of MMF into the therapeutic armamentarium of LN and the extension of the use of the European intravenous cyclophosphamide guideline.
• • Availability of the patient's first renal biopsy specimen preserved for re-evaluation.
• • Availability of essential clinical data to carry out the study.
• • Signature of the informed consent by the patient.
• Exclusion Criteria:
• • - Refusal by the patient to sign the informed consent.