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Completed

NCT Number: NCT04655378

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

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.

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Key information

Conditions

Rheumatoid Purpura Blood Coagulation Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Hypersensitivity IgA Vasculitis Immune Complex Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Purpura Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Montpellier, Montpellier, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient sera from biobank of the FoxTreg study (NCT02317133)

Treatment and study plan

Mass Sepctrometry

Other

Mass spectrometry (LC/MS) of purified immunoglobulins

Primary outcomes

  1. Glycopeptide signature of serum from children with Rheumatoid Purpura

    Time frame: Day 0

    Mass spectrometry to identify the glycopeptides present and their level

Secondary outcomes

  1. Repeatability of mass spectrometry in measuring glycopeptide signature

    Time frame: Day 0

    Mass spectrometry to identify the glycopeptides present and their level

  2. Reproducibility of mass spectrometry in measuring glycopeptide signature

    Time frame: Day 0

    Mass spectrometry to identify the glycopeptides present and their level

  3. Control of conservation of samples for measuring glycopeptide signature

    Time frame: Day 0

    Mass spectrometry to identify the glycopeptides present and their level

  4. Glycopeptide signature of serum from all patients of the cohort

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Day 0

    Mass spectrometry of IgA

  8. Number of subjects with IgA glycosylation abnormalities in each group

    Time frame: Day 0

    Mass spectrometry of IgA

  9. Percentage of subjects with IgA glycosylation abnormalities in each group

    Time frame: Day 0

    Mass spectrometry of IgA

  10. Serum immunoglobulin levels in patients with acute Rheumatoid Purpura and in remission

    Time frame: 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.

    Time frame: Day 0

    Blood cell lines, particularly Treg and Breg (number/mm3)

  12. Serum cytokine levels in patients with acute Rheumatoid Purpura and in remission

    Time frame: 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

    Time frame: Day 0

    Plasma levels of 16S rDNA (copies/µl)

  14. Plasma levels of LBP in patients with Rheumatoid Purpura

    Time frame: Day 0

    µg/ml

  15. Plasma levels of CD14s in patients with Rheumatoid Purpura

    Time frame: Day 0

    µg/ml

  16. Bacterial diversity in the gut microbiota in patients with Rheumatoid Purpura

    Time frame: Day 0

    Diversity Index

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: FOXIGA-2020

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 7, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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