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临床试验/NCT03474536
NCT03474536已完成不适用

Clinical Impact of Concentration and Affinity of HLA-DQ Antibodies in Lung Transplantation - AFFIHLA-P

University Hospital, Bordeaux5 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年3月14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
88
试验地点
5
主要终点
CLAD development

研究概览

简要总结

The aim is to compare the quantitative parameters of de novo anti-HLA DQ Donor Specific Antibodies (DSA), determined at the time of their discovery by surface plasmon resonance (SPR), between recipients that developed a Chronic Lung Allograft Dysfunction (CLAD) for the 2 years following DSA apparition and those who did not. If concentration, kinetics and/or affinity parameters of anti-DQ DSA are associated with CLAD development, new, non-invasive prognostic biomarkers of humoral rejection in lung transplantation will be discovered .

详细描述

After lung transplantation the production of de novo DSA directed against HLA-DQ molecules is associated with CLAD and graft loss. The most used assay for serum DSA detection is the Single Antigen Luminex® (SAG), which provides a semi-quantitative fluorescence value, the MFI, used as a surrogate of DSA "strength". But MFI is not perfectly associated with CLAD development. We developed a method using SPR allowing the concentration, kinetics (ka, kd) and affinity parameters (KD) of anti-DQ DSA to be determined. These quantitative parameters could represent biomarkers finely associated with CLAD. The way this parameters evolve (stability, increase or decrease) with time could also impact on DSA pathogenicity. We will compare the quantitative parameters of de novo anti-HLA DQ DSA, determined at the time of their discovery, between recipients that developed a CLAD for the 2 years following DSA apparition, and those who did not. The association between quantitative parameters of DSA and graft loss, their evolution and its association with CLAD and graft loss, and their correlation with SAG MFI will be also evaluated.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years and older
  • Patient transplanted between 01/01/2001 and 31/07/2016
  • Patient with immunodominant anti-HLA DQ de novo DSA developed before 08/2016
  • Patient for who sufficient remaining serum quantity is available in usual care biobank
  • non-opposition of the patient

排除标准

  • preformed DSA at the transplantation;
  • Non immunodominant DQ DSA ;
  • Insufficient serum quantity in usual care biobank
  • Inability to determine the date of DSA apparition at around one year
  • opposition of the patient

结局指标

主要结局

CLAD development

时间窗: 2 years

CLAD development within the 2 years following DSA apparition

次要结局

  • raft loss up to 5 years following DSA apparition(6 months, 1 year, 2 years, 5 years)
  • CLAD development(1 year)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (5)

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