Validation of the IgA1 Detection Method With Gradient Glycosylation by Mass Spectrometry as a Potential Marker of Renal Involvement in Pediatric Rheumatoid Purpura
- Conditions
- Rheumatoid PurpuraPediatric ALL
- Interventions
- Other: Mass Sepctrometry
- Registration Number
- NCT04655378
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief Summary
In this ancillary study on the FoxTreg cohort, the study investigators will select variables to input and thus develop two models (Linear Discriminant Analysis and Decision Tree). The aim of this study is to validate the method in terms of repeatability, reproducibility, control of pre-analytical conditions and sample conservation, to complete the screening of IgA glycosylation in individuals of the FoxTreg cohort and to refine the glycopeptide signature to predict renal involvement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Patient sera from biobank of the FoxTreg study (NCT02317133)
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute Rheumatoid Purpura Mass Sepctrometry - Controls Mass Sepctrometry Without infection, inflammatory or auto-immune pathology Rheumatoid Purpura in Remission Mass Sepctrometry -
- Primary Outcome Measures
Name Time Method Glycopeptide signature of serum from children with Rheumatoid Purpura Day 0 Mass spectrometry to identify the glycopeptides present and their level
- Secondary Outcome Measures
Name Time Method Bacterial Translocation in patients with Rheumatoid Purpura Day 0 Plasma levels of 16S rDNA (copies/µl)
Control of conservation of samples for measuring glycopeptide signature Day 0 Mass spectrometry to identify the glycopeptides present and their level
Number of subjects with IgA glycosylation abnormalities in each group Day 0 Mass spectrometry of IgA
Percentage of subjects with IgA glycosylation abnormalities in each group Day 0 Mass spectrometry of IgA
Quantification of blood cell lines in patients with acute Rheumatoid Purpura and in remission. Day 0 Blood cell lines, particularly Treg and Breg (number/mm3)
Reproducibility of mass spectrometry in measuring glycopeptide signature Day 0 Mass spectrometry to identify the glycopeptides present and their level
Glycopeptide signature of serum from all patients of the cohort Day 0 Mass spectrometry to identify the glycopeptides present and their level
Plasma levels of LBP in patients with Rheumatoid Purpura Day 0 µg/ml
Serum cytokine levels in patients with acute Rheumatoid Purpura and in remission Day 0 pg/ml of TGF-β, IL-1, IL-6, TNF-α, IL-8, IL-10 and IL-17
Repeatability of mass spectrometry in measuring glycopeptide signature Day 0 Mass spectrometry to identify the glycopeptides present and their level
Difference between a normally glycosylated IgA and an IgA with GalNac polymer in Rheumatoid Purpura patients with / without renal impairment versus controls Day 0 Mass spectrometry to identify the glycopeptides present and their level
Serum immunoglobulin levels in patients with acute Rheumatoid Purpura and in remission Day 0 Mass spectrometry of immunoglobulins IgA, IgM and IgG (g/L)
Bacterial diversity in the gut microbiota in patients with Rheumatoid Purpura Day 0 Diversity Index
Percentage of subjects with IgA glycosylation abnormalities in Rheumatoid Purpura patient population with renal impairment polymer in Rheumatoid Purpura patients with / without renal impairment versus controls Day 0 Mass spectrometry of IgA
Number of subjects with IgA glycosylation abnormalities in Rheumatoid Purpura patient population with renal impairment polymer in Rheumatoid Purpura patients with / without renal impairment versus controls Day 0 Mass spectrometry of IgA
Plasma levels of CD14s in patients with Rheumatoid Purpura Day 0 µg/ml
Trial Locations
- Locations (2)
CHU de Nimes
🇫🇷Nîmes, France
CHRU de Montpellier
🇫🇷Montpellier, France