Status:
UNKNOWN
Precision Medicine in LN: A Multicenter Proof-of-concept Study for Histopathological Biomarkers Analysis in Renal Biopsy
Lead Sponsor:
Fundacin Biomedica Galicia Sur
Collaborating Sponsors:
Hospital Universitario 12 de Octubre
Germans Trias i Pujol Hospital
Conditions:
Lupus Nephritis
Systemic Lupus Erythematosus
Eligibility:
All Genders
Brief Summary
Lupus nephritis (LN) may affect approximately half of patients with Systemic Lupus Erythematosus (SLE). LN is a major cause of morbidity and the most important predictor of mortality in patients with ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- \- Refusal by the patient to sign the informed consent.
Key Trial Info
Start Date :
October 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 15 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05358652
Start Date
October 15 2021
End Date
January 15 2023
Last Update
May 3 2022
Active Locations (1)
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1
IRIDIS-VIGO Group (Investigation in Rheumatology and Immune-Mediated Diseases), Instituto de Investigación Sanitaria Galicia Sur (IISGS).
Vigo, Pontevedra, Spain, 36213