NCT04655378已完成不适用
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
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年10月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Glycopeptide signature of serum from children with Rheumatoid Purpura
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient sera from biobank of the FoxTreg study (NCT02317133)
排除标准
- 未提供
结局指标
主要结局
Glycopeptide signature of serum from children with Rheumatoid Purpura
时间窗: Day 0
Mass spectrometry to identify the glycopeptides present and their level
次要结局
- Quantification of blood cell lines in patients with acute Rheumatoid Purpura and in remission.(Day 0)
- Reproducibility of mass spectrometry in measuring glycopeptide signature(Day 0)
- Glycopeptide signature of serum from all patients of the cohort(Day 0)
- Repeatability of mass spectrometry in measuring glycopeptide signature(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)
- Serum immunoglobulin levels in patients with acute Rheumatoid Purpura and in remission(Day 0)
- Serum cytokine levels in patients with acute Rheumatoid Purpura and in remission(Day 0)
- Plasma levels of LBP in patients with Rheumatoid Purpura(Day 0)
- Bacterial diversity in the gut microbiota in patients with Rheumatoid Purpura(Day 0)
- 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(Day 0)
- Bacterial Translocation in patients with Rheumatoid Purpura(Day 0)
- Control of conservation of samples for measuring glycopeptide signature(Day 0)
- Number of subjects with IgA glycosylation abnormalities in each group(Day 0)
- Percentage of subjects with IgA glycosylation abnormalities in each group(Day 0)
- 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(Day 0)
- Plasma levels of CD14s in patients with Rheumatoid Purpura(Day 0)
研究者
研究点 (2)
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