Lorenzon Roberta, Mariotti-Ferrandiz Encarnita, Aheng Caroline, Ribet Claire, Toumi Ferial, Pitoiset Fabien, Chaara Wahiba, Derian Nicolas, Johanet Catherine, Drakos Iannis, Harris Sophie, Amselem Serge, Berenbaum Francis, Benveniste Olivier, Bodaghi Bahram, Cacoub Patrice, Grateau Gilles, Amouyal Chloe, Hartemann Agnes, Saadoun David, Sellam Jeremie, Seksik Philippe, Sokol Harry, Salem Joe-Elie, Vicaut Eric, Six Adrien, Rosenzwajg Michelle, Bernard Claude, Klatzmann David
Immunology, Immunopathology, Immunotherapy (i3), Sorbonne Université, INSERM, Paris, France.
Biotherapy (CIC-BTi) and Inflammation, Immunopathology, Biotherapy Department (i2B), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
BMJ Open. 2018 Aug 30;8(8):e021037. doi: 10.1136/bmjopen-2017-021037.
Autoimmune and autoinflammatory diseases (AIDs) represent a socioeconomic burden as the second cause of chronic illness in Western countries. In this context, the TRANSIMMUNOM clinical protocol is designed to revisit the nosology of AIDs by combining basic, clinical and information sciences. Based on classical and systems biology analyses, it aims to uncover important phenotypes that cut across diagnostic groups so as to discover biomarkers and identify novel therapeutic targets.
TRANSIMMUNOM is an observational clinical protocol that aims to cross-phenotype a set of 19 AIDs, six related control diseases and healthy volunteers . We assembled a multidisciplinary cohort management team tasked with (1) selecting informative biological (routine and omics type) and clinical parameters to be captured, (2) standardising the sample collection and shipment circuit, (3) selecting omics technologies and benchmarking omics data providers, (4) designing and implementing a multidisease electronic case report form and an omics database and (5) implementing supervised and unsupervised data analyses.
The study was approved by the institutional review board of Pitié-Salpêtrière Hospital (ethics committee Ile-De-France 48-15) and done in accordance with the Declaration of Helsinki and good clinical practice. Written informed consent is obtained from all participants before enrolment in the study. TRANSIMMUNOM's project website provides information about the protocol (https://www.transimmunom.fr/en/) including experimental set-up and tool developments. Results will be disseminated during annual scientific committees appraising the project progresses and at national and international scientific conferences.
Systems biology approaches are increasingly implemented in human pathophysiology research. The TRANSIMMUNOM study applies such approach to the pathophysiology of AIDs. We believe that this translational systems immunology approach has the potential to provide breakthrough discoveries for better understanding and treatment of AIDs.
NCT02466217; Pre-results.
自身免疫性疾病和自身炎症性疾病（AIDs）是西方国家慢性疾病的第二大病因，构成了社会经济负担。在此背景下，TRANSIMMUNOM临床方案旨在通过整合基础科学、临床科学和信息科学来重新审视AIDs的疾病分类学。基于经典生物学和系统生物学分析，该方案旨在揭示跨越诊断组的重要表型，从而发现生物标志物并确定新的治疗靶点。
TRANSIMMUNOM是一项观察性临床方案，旨在对19种AIDs、6种相关对照疾病和健康志愿者进行跨表型研究。我们组建了一个多学科队列管理团队，负责：（1）选择需要采集的信息丰富的生物学（常规和组学类型）及临床参数；（2）规范样本采集和运输流程；（3）选择组学技术并对组学数据供应商进行基准测试；（4）设计并实施多疾病电子病例报告表和组学数据库；（5）实施监督和非监督数据分析。
该研究已获得皮提耶 - 萨尔佩特里埃医院机构审查委员会（法兰西岛伦理委员会48 - 15）的批准，并按照《赫尔辛基宣言》和良好临床实践开展。在研究入组前，已获得所有参与者的书面知情同意。TRANSIMMUNOM项目网站提供了有关该方案的信息（https://www.transimmunom.fr/en/），包括实验设置和工具开发。研究结果将在评估项目进展的年度科学委员会会议以及国内和国际科学会议上发布。
系统生物学方法在人类病理生理学研究中的应用日益广泛。TRANSIMMUNOM研究将这种方法应用于AIDs的病理生理学研究。我们认为，这种转化系统免疫学方法有可能为更好地理解和治疗AIDs带来突破性发现。
NCT02466217；预结果。
