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世界子宫内膜异位症研究基金会子宫内膜异位症表型与生物样本库协调项目:四、子宫内膜异位症研究中的组织采集、处理及储存

World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project: IV. Tissue collection, processing, and storage in endometriosis research.

作者信息

Fassbender Amelie, Rahmioglu Nilufer, Vitonis Allison F, Viganò Paola, Giudice Linda C, D'Hooghe Thomas M, Hummelshoj Lone, Adamson G David, Becker Christian M, Missmer Stacey A, Zondervan Krina T

机构信息

Organ Systems, Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, Leuven University Fertility Center, University Hospital Leuven, Leuven, Belgium.

Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, United Kingdom.

出版信息

Fertil Steril. 2014 Nov;102(5):1244-53. doi: 10.1016/j.fertnstert.2014.07.1209. Epub 2014 Sep 22.

Abstract

OBJECTIVE

To harmonize standard operating procedures (SOPs) and standardize the recording of associated data for collection, processing, and storage of human tissues relevant to endometriosis.

DESIGN

An international collaboration involving 34 clinical/academic centers and three industry collaborators from 16 countries on five continents.

SETTING

In 2013, two workshops were conducted followed by global consultation, bringing together 54 leaders in endometriosis research and sample processing from around the world.

PATIENT(S): None.

INTERVENTION(S): Consensus SOPs were based on: 1) systematic comparison of SOPs from 24 global centers collecting tissue samples from women with and without endometriosis on a medium or large scale (publication on >100 cases); 2) literature evidence where available, or consultation with laboratory experts otherwise; and 3) several global consultation rounds.

MAIN OUTCOME MEASURE(S): Standard recommended and minimum required SOPs for tissue collection, processing, and storage in endometriosis research.

RESULT(S): We developed "recommended standard" and "minimum required" SOPs for the collection, processing, and storage of ectopic and eutopic endometrium, peritoneum, and myometrium, and a biospecimen data collection form necessary for interpretation of sample-derived results.

CONCLUSION(S): The EPHect SOPs allow endometriosis research centers to decrease variability in tissue-based results, facilitating between-center comparisons and collaborations. The procedures are also relevant to research into other gynecologic conditions involving endometrium, myometrium, and peritoneum. The consensus SOPs are based on the best available evidence; areas with limited evidence are identified as requiring further pilot studies. The SOPs will be reviewed based on investigator feedback and through systematic triannual follow-up. Updated versions will be made available at: http://endometriosisfoundation.org/ephect.

摘要

目的

协调标准操作程序(SOP),规范与子宫内膜异位症相关的人体组织采集、处理和存储的相关数据记录。

设计

一项国际合作项目,涉及来自五大洲16个国家的34个临床/学术中心和3个行业合作伙伴。

背景

2013年举办了两次研讨会,随后进行全球咨询,汇聚了来自世界各地的54位子宫内膜异位症研究和样本处理领域的领导者。

患者

无。

干预措施

共识性SOP基于以下几点:1)对24个全球中心的SOP进行系统比较,这些中心从中等或大规模收集患有和未患有子宫内膜异位症女性的组织样本(发表病例数>100例);2)现有文献证据,否则咨询实验室专家;3)多次全球咨询轮次。

主要观察指标

子宫内膜异位症研究中组织采集、处理和存储的标准推荐和最低要求SOP。

结果

我们制定了异位和在位子宫内膜、腹膜和子宫肌层采集、处理和存储的“推荐标准”和“最低要求”SOP,以及解释样本衍生结果所需的生物样本数据收集表。

结论

EPHect SOP使子宫内膜异位症研究中心能够减少基于组织的结果差异,促进中心间比较和合作。这些程序也与涉及子宫内膜、子宫肌层和腹膜的其他妇科疾病研究相关。共识性SOP基于现有最佳证据;证据有限的领域被确定需要进一步的试点研究。SOP将根据研究者反馈并通过每三年一次的系统随访进行审查。更新版本可在以下网址获取:http://endometriosisfoundation.org/ephect

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d5b/4230778/696a38ccfff4/gr1.jpg

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