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Rheumatoid PurpuraFOXIGA-2020NCT04655378

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 of Rheumatoid Purpura and Pediatric ALL, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 3 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Rheumatoid Purpura, Pediatric ALL
What is being tested?
Mass Sepctrometry
How many people
52 participants
Where
2 sitesFrance
Study dates
22 Oct 2020to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHRU de Montpellier

    Montpellier

  • CHU de Nimes

    Nîmes

Other trials in France

About this study

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

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.

Being tested
Mass Sepctrometry
Medical subject headings
IgA Vasculitis, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mass SepctrometryOther

    Mass spectrometry (LC/MS) of purified immunoglobulins

Study groups in NCT04655378
Study groupRoleWhat they receive
Acute Rheumatoid PurpuraNot described
Receives: Other: Mass Sepctrometry
Rheumatoid Purpura in RemissionNot described
Receives: Other: Mass Sepctrometry
ControlsWithout infection, inflammatory or auto-immune pathology
Receives: Other: Mass Sepctrometry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycopeptide signature of serum from children with Rheumatoid Purpura

    Mass spectrometry to identify the glycopeptides present and their level

    Measured: Day 0

Secondary outcomes (16)

  1. Repeatability of mass spectrometry in measuring glycopeptide signature

    Mass spectrometry to identify the glycopeptides present and their level

    Measured: Day 0

  2. Reproducibility of mass spectrometry in measuring glycopeptide signature

    Mass spectrometry to identify the glycopeptides present and their level

    Measured: Day 0

  3. Control of conservation of samples for measuring glycopeptide signature

    Mass spectrometry to identify the glycopeptides present and their level

    Measured: Day 0

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

    Mass spectrometry to identify the glycopeptides present and their level

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Day 0

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

    Mass spectrometry of IgA

    Measured: Day 0

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

    Mass spectrometry of IgA

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: Day 0

  13. Bacterial Translocation in patients with Rheumatoid Purpura

    Plasma levels of 16S rDNA (copies/µl)

    Measured: Day 0

  14. Plasma levels of LBP in patients with Rheumatoid Purpura

    µg/ml

    Measured: Day 0

  15. Plasma levels of CD14s in patients with Rheumatoid Purpura

    µg/ml

    Measured: Day 0

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

    Diversity Index

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2020
  2. Study start22 Oct 2020
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04655378
Sponsor's protocol ID
NIMAO/2020-1/TAT-01
Acronym
FOXIGA-2020
Status last verified
Feb 2023
First submitted
30 Nov 2020
Last updated
8 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Purpura and Pediatric ALL, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycopeptide signature of serum from children with Rheumatoid Purpura (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04655378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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