FOXIGA-2020: Validation of the IgA1 Detection Method With Gradient Glycosylation by Mass Spectrometry as a Potential Marker of Renal Involvement in Pediatric Rheumatoid Purpura

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04655378
Collaborator
(none)
52
2
25.3
26
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mass Sepctrometry

Study Design

Study Type:
Observational
Actual Enrollment :
52 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
Oct 22, 2020
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Acute Rheumatoid Purpura

Other: Mass Sepctrometry
Mass spectrometry (LC/MS) of purified immunoglobulins

Rheumatoid Purpura in Remission

Other: Mass Sepctrometry
Mass spectrometry (LC/MS) of purified immunoglobulins

Controls

Without infection, inflammatory or auto-immune pathology

Other: Mass Sepctrometry
Mass spectrometry (LC/MS) of purified immunoglobulins

Outcome Measures

Primary Outcome Measures

  1. Glycopeptide signature of serum from children with Rheumatoid Purpura [Day 0]

    Mass spectrometry to identify the glycopeptides present and their level

Secondary Outcome Measures

  1. Repeatability of mass spectrometry in measuring glycopeptide signature [Day 0]

    Mass spectrometry to identify the glycopeptides present and their level

  2. Reproducibility of mass spectrometry in measuring glycopeptide signature [Day 0]

    Mass spectrometry to identify the glycopeptides present and their level

  3. Control of conservation of samples for measuring glycopeptide signature [Day 0]

    Mass spectrometry to identify the glycopeptides present and their level

  4. Glycopeptide signature of serum from all patients of the cohort [Day 0]

    Mass spectrometry to identify the glycopeptides present and their level

  5. 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

  6. 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

  7. 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

  8. Number of subjects with IgA glycosylation abnormalities in each group [Day 0]

    Mass spectrometry of IgA

  9. Percentage of subjects with IgA glycosylation abnormalities in each group [Day 0]

    Mass spectrometry of IgA

  10. Serum immunoglobulin levels in patients with acute Rheumatoid Purpura and in remission [Day 0]

    Mass spectrometry of immunoglobulins IgA, IgM and IgG (g/L)

  11. 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)

  12. 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

  13. Bacterial Translocation in patients with Rheumatoid Purpura [Day 0]

    Plasma levels of 16S rDNA (copies/µl)

  14. Plasma levels of LBP in patients with Rheumatoid Purpura [Day 0]

    µg/ml

  15. Plasma levels of CD14s in patients with Rheumatoid Purpura [Day 0]

    µg/ml

  16. Bacterial diversity in the gut microbiota in patients with Rheumatoid Purpura [Day 0]

    Diversity Index

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Patient sera from biobank of the FoxTreg study (NCT02317133)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU de Montpellier Montpellier France
2 CHU de Nimes Nîmes France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Tu Anh TRAN, CHU de Nimes

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT04655378
Other Study ID Numbers:
  • NIMAO/2020-1/TAT-01
First Posted:
Dec 7, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022