World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project: III. Fluid biospecimen collection, processing, and storage in endometriosis research

Abstract

ObjectiveTo harmonize standard operating procedures (SOPs) and standardize the recording of associated data for collection, processing, and storage of fluid biospecimens relevant to endometriosis.DesignAn international collaboration involving 34 clinical/academic centers and 3 industry collaborators from 16 countries on 5 continents.SettingIn 2013, 2 workshops were conducted, followed by global consultation, bringing together 54 leaders in endometriosis research and sample processing worldwide.Patient(s)None.Intervention(s)Consensus SOPs were based on: [1] systematic comparison of SOPs from 18 global centers collecting fluid samples from women with and without endometriosis on a medium/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 biofluid collection, processing, and storage in endometriosis research.Result(s)We developed recommended standard and minimum required SOPs for the collection, processing, and storage of plasma, serum, saliva, urine, endometrial/peritoneal fluid, and menstrual effluent, and a biospecimen data-collection form necessary for interpretation of sample-derived results.Conclusion(s)The Endometriosis Phenome and Biobanking Harmonisation Project SOPs allow endometriosis research centers to decrease variability in biofluid sample results, facilitating between-center comparisons and collaborations. The procedures are also relevant to research into other female conditions involving biofluid samples subject to cyclic reproductive influences. 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 tri-annual follow-up. Updated versions will be made available at: endometriosisfoundation.org/ephect.

Research Priorities for Endometriosis: Recommendations From a Global Consortium of Investigators in Endometriosis

“…Of note and directly emanating from recommendations at the 2011 workshop are the publications from the EPHect. 3,4,11,12 Lack of progress in other research areas may reflect the complexities of problems to be addressed, as well as the relatively slow pace of research and limited funding globally.…”

World Endometriosis Society consensus on the classification of endometriosis

“…Collaborative data collection in a manner described in the WERF EPHect papers highlighting the need for harmonisation of the endometriosis phenome (i.e. the set of all phenotypes expressed), data collection, and specimen handling Vitonis et al, 2014;Rahmioglu et al, 2014;Fassbender et al, 2014) is the key to unlock this considerable potential.…”

An evidence‐based approach to assessing surgical versus clinical diagnosis of symptomatic endometriosis

“…Development of biomarkers in the context of endometriosis would be bolstered by well‐designed studies that include biomarkers in conjunction with other clinical diagnostic measures. The World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project is making progress toward enhanced understanding through global research collaboration …”