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Validation of the IgA1 Detection Method With Gradient Glycosylation by Mass Spectrometry as a Potential Marker of Renal Involvement in Pediatric Rheumatoid Purpura

Recherche d'un Marqueur Pronostique de l'Atteinte rénale du Purpura Rhumatoïde de l'Enfant. Validation de la méthode de détection Des IgA1 Avec Gradient de la Glycosylation Par spectrométrie de Masse

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04655378
Acronym
FOXIGA-2020
Enrollment
52
Registered
2020-12-07
Start date
2020-10-22
Completion date
2022-12-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric ALL, Rheumatoid Purpura

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.

Interventions

OTHERMass Sepctrometry

Mass spectrometry (LC/MS) of purified immunoglobulins

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

Patient sera from biobank of the FoxTreg study (NCT02317133)

Design outcomes

Primary

MeasureTime frameDescription
Glycopeptide signature of serum from children with Rheumatoid PurpuraDay 0Mass spectrometry to identify the glycopeptides present and their level

Secondary

MeasureTime frameDescription
Reproducibility of mass spectrometry in measuring glycopeptide signatureDay 0Mass spectrometry to identify the glycopeptides present and their level
Control of conservation of samples for measuring glycopeptide signatureDay 0Mass spectrometry to identify the glycopeptides present and their level
Glycopeptide signature of serum from all patients of the cohortDay 0Mass 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 controlsDay 0Mass spectrometry to identify the glycopeptides present and their level
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 controlsDay 0Mass spectrometry of IgA
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 controlsDay 0Mass spectrometry of IgA
Number of subjects with IgA glycosylation abnormalities in each groupDay 0Mass spectrometry of IgA
Repeatability of mass spectrometry in measuring glycopeptide signatureDay 0Mass spectrometry to identify the glycopeptides present and their level
Serum immunoglobulin levels in patients with acute Rheumatoid Purpura and in remissionDay 0Mass spectrometry of immunoglobulins IgA, IgM and IgG (g/L)
Quantification of blood cell lines in patients with acute Rheumatoid Purpura and in remission.Day 0Blood cell lines, particularly Treg and Breg (number/mm3)
Serum cytokine levels in patients with acute Rheumatoid Purpura and in remissionDay 0pg/ml of TGF-β, IL-1, IL-6, TNF-α, IL-8, IL-10 and IL-17
Bacterial Translocation in patients with Rheumatoid PurpuraDay 0Plasma levels of 16S rDNA (copies/µl)
Plasma levels of LBP in patients with Rheumatoid PurpuraDay 0µg/ml
Plasma levels of CD14s in patients with Rheumatoid PurpuraDay 0µg/ml
Bacterial diversity in the gut microbiota in patients with Rheumatoid PurpuraDay 0Diversity Index
Percentage of subjects with IgA glycosylation abnormalities in each groupDay 0Mass spectrometry of IgA

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026