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

Pediatric ALL Clinical Trial

— FOXIGA-2020  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655378
• Other study ID #: NIMAO/2020-1/TAT-01
• Status: Completed
• Start date: October 22, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

Inclusion Criteria:

Patient sera from biobank of the FoxTreg study (NCT02317133)

Related Conditions & MeSH terms

• Pediatric ALL
• Purpura
• Purpura, Schoenlein-Henoch
• Rheumatoid Purpura

Intervention

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

Locations

Country	Name	City	State
France	CHRU de Montpellier	Montpellier
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycopeptide signature of serum from children with Rheumatoid Purpura	Mass spectrometry to identify the glycopeptides present and their level	Day 0
Secondary	Repeatability of mass spectrometry in measuring glycopeptide signature	Mass spectrometry to identify the glycopeptides present and their level	Day 0
Secondary	Reproducibility of mass spectrometry in measuring glycopeptide signature	Mass spectrometry to identify the glycopeptides present and their level	Day 0
Secondary	Control of conservation of samples for measuring glycopeptide signature	Mass spectrometry to identify the glycopeptides present and their level	Day 0
Secondary	Glycopeptide signature of serum from all patients of the cohort	Mass spectrometry to identify the glycopeptides present and their level	Day 0
Secondary	Difference between a normally glycosylated IgA and an IgA with GalNac polymer in Rheumatoid Purpura patients with / without renal impairment versus controls	Mass spectrometry to identify the glycopeptides present and their level	Day 0
Secondary	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	Mass spectrometry of IgA	Day 0
Secondary	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	Mass spectrometry of IgA	Day 0
Secondary	Number of subjects with IgA glycosylation abnormalities in each group	Mass spectrometry of IgA	Day 0
Secondary	Percentage of subjects with IgA glycosylation abnormalities in each group	Mass spectrometry of IgA	Day 0
Secondary	Serum immunoglobulin levels in patients with acute Rheumatoid Purpura and in remission	Mass spectrometry of immunoglobulins IgA, IgM and IgG (g/L)	Day 0
Secondary	Quantification of blood cell lines in patients with acute Rheumatoid Purpura and in remission.	Blood cell lines, particularly Treg and Breg (number/mm3)	Day 0
Secondary	Serum cytokine levels in patients with acute Rheumatoid Purpura and in remission	pg/ml of TGF-ß, IL-1, IL-6, TNF-a, IL-8, IL-10 and IL-17	Day 0
Secondary	Bacterial Translocation in patients with Rheumatoid Purpura	Plasma levels of 16S rDNA (copies/µl)	Day 0
Secondary	Plasma levels of LBP in patients with Rheumatoid Purpura	µg/ml	Day 0
Secondary	Plasma levels of CD14s in patients with Rheumatoid Purpura	µg/ml	Day 0
Secondary	Bacterial diversity in the gut microbiota in patients with Rheumatoid Purpura	Diversity Index	Day 0