NCT04889573已完成不适用
Immunoglobulin Gene Rearrangement and Repair in Healthy Donors
University Hospital, Limoges2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年7月7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
- 120
- 试验地点
- 2
- 主要终点
- Frequency of use of the V, D and J genes in VDJ rearrangements
研究概览
简要总结
B-cells ensure humoral immune response against antigens (Ag) thanks to their receptor (BCR). V(D)J rearrangement, somatic hypermutation, immunoglobulin (Ig) class switch and locus suicide recombination are mutational/recombinational processes targeting Ig loci influencing BCR expression. Study of these events is essential for B cell function analysis. Our project will provide the normal reference values using high throughput sequencing-based protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers aged between 18 and 70
- •volunteers free from lymphoid hemopathy, immune deficiency and autoimmune disease.
- •3 categories : volunteers between 18 and 34 years of age, volunteers between 35 and 50 years of age, volunteers between 51 and 69 years of age.
排除标准
- •any recent vaccination (< 4 weeks)
- •tumoral pathology
- •lymphoïd hemopathy
- •immune deficiency
- •autoimmune disease
- •transplanted patients
- •inflammatory / systemic diseases
- •hypersensitivity or allergies
- •treatments likely to modify the immune response :
- •calcineurin inhibitors: ciclosporin, tacrolimus -antimetabolite: azathioprine, mycophenolate mofetil / mycophenolic acid, 6-mercaptopurine, methotrexate
- •cyclophosphamide
- •antilymphocyte serum (rabbit, horse)
- •mTOR inhibitors: everolimus, sirolimus
- •anti-CD25 (anti IL2-R): basiliximab, dacliximab -belatacept (anti CD80-86)
- •abatacept (CTLA4-Ig)
- •OKT3 (Muronomab-CD3, anti-CD23)
- •glucocorticoids: methylprednisolone, prednisone, prednisolone.
- •entuzumab (anti-CD52)
- •rituximab, ocrelizumab (anti-CD20)
- •eculizumab (anti-C5)
- •anakinra (analogue IL1-RA)
- •leflunomide (dihydroorotate dehydrogenase inhibition)
- •bortezomib (proteasome inhibitor)
- •fingolimod (S1P receptor antagonist)
- •alentuzumab (anti CD52)
- •Ig G -antiTNF (etanercept, infliximab, adalimumab, certolizumab)
- •vedolizumab (Anti-integrin α4β7 Ab)
- •ustekinumab (anti-IL12)
- •natalizumab (anti-integrin a4)
- •mitoxantrone (topoisomerase type II inhibitor)
- •tocilizumab (anti-IL6)
结局指标
主要结局
Frequency of use of the V, D and J genes in VDJ rearrangements
时间窗: through study completion, an average of 18 months
次要结局
- Percentage of HyperMutation Somatic (SHM) in VDJ regions(through study completion, an average of 18 months)
- Ig class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions(through study completion, an average of 18 months)
- Frequency of g class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions(through study completion, an average of 18 months)
- Nature of HyperMutation Somatic (SHM)(through study completion, an average of 18 months)
研究者
研究点 (2)
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