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CompletedNCT04655378FOXIGA-2020Updated Feb 8, 2023

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

An observational study in Rheumatoid Purpura and Pediatric ALL, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 2 sites in France. Open to participants aged 3 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
52
Ages
3 Years to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Purpura
  • Pediatric ALL
03

In context

IgA Vasculitis

36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.

This study's enrollment of 52 is below the median of 300 across 17 observational studies indexed under IgA Vasculitis.

Browse IgA Vasculitis studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Browse Centre Hospitalier Universitaire de Nīmes studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Eligibility criteria

Inclusion Criteria:

Patient sera from biobank of the FoxTreg study (NCT02317133)

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
52 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherMass Sepctrometry

    Mass spectrometry (LC/MS) of purified immunoglobulins

06

What researchers measure

Primary outcomes

  1. Glycopeptide signature of serum from children with Rheumatoid Purpura

    Mass spectrometry to identify the glycopeptides present and their level

    Time frame: Day 0

Secondary outcomes

  1. Repeatability of mass spectrometry in measuring glycopeptide signature

    Mass spectrometry to identify the glycopeptides present and their level

    Time frame: Day 0

  2. Reproducibility of mass spectrometry in measuring glycopeptide signature

    Mass spectrometry to identify the glycopeptides present and their level

    Time frame: Day 0

  3. Control of conservation of samples for measuring glycopeptide signature

    Mass spectrometry to identify the glycopeptides present and their level

    Time frame: Day 0

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

    Mass spectrometry to identify the glycopeptides present and their level

    Time frame: Day 0

  5. 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

    Time frame: Day 0

  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

    Mass spectrometry of IgA

    Time frame: Day 0

  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

    Mass spectrometry of IgA

    Time frame: Day 0

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

    Mass spectrometry of IgA

    Time frame: Day 0

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

    Mass spectrometry of IgA

    Time frame: Day 0

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

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

    Time frame: Day 0

  11. Quantification of blood cell lines in patients with acute Rheumatoid Purpura and in remission.

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

    Time frame: Day 0

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

    pg/ml of TGF-β, IL-1, IL-6, TNF-α, IL-8, IL-10 and IL-17

    Time frame: Day 0

  13. Bacterial Translocation in patients with Rheumatoid Purpura

    Plasma levels of 16S rDNA (copies/µl)

    Time frame: Day 0

  14. Plasma levels of LBP in patients with Rheumatoid Purpura

    µg/ml

    Time frame: Day 0

  15. Plasma levels of CD14s in patients with Rheumatoid Purpura

    µg/ml

    Time frame: Day 0

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

    Diversity Index

    Time frame: Day 0

07

Study locations

2 sites
  • CHRU de Montpellier
    Montpellier, France
  • CHU de Nimes
    Nîmes, France
08

References and documents

Publications

  • 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. PubMed 20413568 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2020 to primary completion in Dec 2021, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2020
First posted
Dec 7, 2020
StartActual
Oct 22, 2020
Primary completionActual
Dec 31, 2021
CompletionActual
Dec 31, 2022
Last update
Feb 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04655378
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Dec 7, 2020
Start date
Oct 22, 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2022
Last update
Feb 8, 2023

Study contacts

Tu Anh TRAN
principal investigator · CHU de Nimes

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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