Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia.
BMJ Open. 2024 Sep 12;14(9):e085504. doi: 10.1136/bmjopen-2024-085504.
The human gut microbiota has the potential to modulate the outcomes of several human diseases. This effect is likely to be mediated through interaction with the host immune system. This protocol details the establishment of a biorepository of clinically annotated samples, which we will use to explore correlations between the gut microbiota and the immune system of immune-compromised patients. We aim to identify microbiome-related risk factors for adverse outcomes.
This is a protocol for the development of a biorepository of clinically annotated samples collected prospectively across three centres in Melbourne, Australia. Participants will be recruited across the following clinical streams: (1) acute leukaemia and allogeneic stem cell transplant; (2) end-stage liver disease and liver transplant; (3) patients receiving any cancer immunotherapies (eg, chimeric antigen receptor therapy); (4) deceased organ donors and (5) healthy adult controls. Participants will be asked to provide paired peripheral blood and microbiota samples (stool and saliva) at either (1) single time point for healthy controls and deceased organ donors or (2) longitudinally over multiple prespecified or event-driven time points for the remaining cohorts. Sampling of fluid from bronchoalveolar lavage and colonoscopy or biopsy of tissues undertaken during routine care will also be performed.
Ethical approval has been obtained from the relevant local ethics committee (The Royal Melbourne Hospital Human Research Ethics Committee). The results of this study will be disseminated by various scientific platforms including social media, international presentations and publication in peer-reviewed journals.
ACTRN12623001105639. Date registered 20 October 2023.
人类肠道微生物群有可能调节多种人类疾病的结果。这种影响很可能是通过与宿主免疫系统的相互作用介导的。本方案详细介绍了临床注释样本生物库的建立，我们将使用该生物库来探索免疫功能低下患者的肠道微生物群与免疫系统之间的相关性。我们旨在确定与肠道微生物群相关的不良结果的风险因素。
这是一个在澳大利亚墨尔本的三个中心前瞻性收集临床注释样本的生物库开发方案。参与者将通过以下临床途径招募：（1）急性白血病和异基因干细胞移植；（2）终末期肝病和肝移植；（3）接受任何癌症免疫疗法（例如嵌合抗原受体治疗）的患者；（4）已故器官捐献者和（5）健康成年对照。参与者将被要求在以下两种情况下提供配对的外周血和微生物群样本（粪便和唾液）：（1）对于健康对照和已故器官捐献者，仅在一个时间点进行；或（2）对于其余队列，在多个预先指定或事件驱动的时间点进行纵向采样。在常规护理过程中进行的支气管肺泡灌洗和结肠镜检查或组织活检时，还将抽取液体样本。
已从相关的当地伦理委员会（皇家墨尔本医院人类研究伦理委员会）获得伦理批准。本研究的结果将通过各种科学平台传播，包括社交媒体、国际演讲和同行评议期刊的发表。
ACTRN12623001105639。注册日期：2023 年 10 月 20 日。
