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

NCT04655378 | Completed

• 1 other identifier: NIMAO/2020-1/TAT-01
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Purpura; Pediatric ALL

Outcome Measures

Primary Outcomes (1)

• Glycopeptide signature of serum from children with Rheumatoid Purpura

  Mass spectrometry to identify the glycopeptides present and their level

  Day 0

Secondary Outcomes (16)

• Repeatability of mass spectrometry in measuring glycopeptide signature

  Day 0

• Reproducibility of mass spectrometry in measuring glycopeptide signature

  Day 0

• Control of conservation of samples for measuring glycopeptide signature

  Day 0

• Glycopeptide signature of serum from all patients of the cohort

  Day 0

• Difference between a normally glycosylated IgA and an IgA with GalNac polymer in Rheumatoid Purpura patients with / without renal impairment versus controls

  Day 0

Study Arms (3)

Acute Rheumatoid Purpura

Other: Mass Sepctrometry

Rheumatoid Purpura in Remission

Other: Mass Sepctrometry

Controls

Without infection, inflammatory or auto-immune pathology

Other: Mass Sepctrometry

Interventions

Mass Sepctrometry OTHER

Mass spectrometry (LC/MS) of purified immunoglobulins

Acute Rheumatoid Purpura; Controls; Rheumatoid Purpura in Remission

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This is an ancillary study on the patient biobank of the FoxTreg study (NCT02317133). All these patients had given their consent for blood sampling and the conservation of biological samples within the Biological Resources Center (CRB) of Nîmes. A total of 97 patients were recruited, forming three groups: * Group A (n = 30): patients with active Rheumatoid Purpura according to the criteria of EULAR / PRES / PRINTO 2010 \[Ozen et al. 2010\]. * Group B (n = 30): patients in remission of Rheumatoid Purpura according to the criteria of EULAR / PRES / PRINTO 2010 \[Ozen et al. 2010\]. * Group C (n = 37): age-matched control subjects free of infectious / inflammatory / autoimmune pathology. For this "FoxIgA-2020" study, only sera collected from these patients not analyzed in the "FoxIgA" study will be used. Thus 52 samples will be analyzed for the FoxIgA-2020 study: * 10 sera from group A * 14 sera from group B * 28 sera of group C

You may qualify if:

• Patient sera from biobank of the FoxTreg study (NCT02317133)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHRU de Montpellier

Montpellier, France

Location

CHU de Nimes

Nîmes, France

Location

Related Publications (1)

• Ozen S, Pistorio A, Iusan SM, Bakkaloglu A, Herlin T, Brik R, Buoncompagni A, Lazar C, Bilge I, Uziel Y, Rigante D, Cantarini L, Hilario MO, Silva CA, Alegria M, Norambuena X, Belot A, Berkun Y, Estrella AI, Olivieri AN, Alpigiani MG, Rumba I, Sztajnbok F, Tambic-Bukovac L, Breda L, Al-Mayouf S, Mihaylova D, Chasnyk V, Sengler C, Klein-Gitelman M, Djeddi D, Nuno L, Pruunsild C, Brunner J, Kondi A, Pagava K, Pederzoli S, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). EULAR/PRINTO/PRES criteria for Henoch-Schonlein purpura, childhood polyarteritis nodosa, childhood Wegener granulomatosis and childhood Takayasu arteritis: Ankara 2008. Part II: Final classification criteria. Ann Rheum Dis. 2010 May;69(5):798-806. doi: 10.1136/ard.2009.116657.

  PMID: 20413568 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples already in existence

MeSH Terms

Conditions

IgA Vasculitis; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Immune Complex Diseases; Hypersensitivity; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Tu Anh TRAN

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: October 22, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (2)