PB2054 HOVON PATHOLOGY FACILITY AND BIOBANK: AN EFFICIENT PLATFORM FOR PATHOLOGY REVIEW AND TRANSLATIONAL STUDIES FOR CLINICAL TRIALS IN LYMPHOMA PATIENTS
Authors: N. Hijmering, E. van Iperen, M. Chamuleau, R. Azevedo, E. Lugtenburg, M.-J. Kersten, M. Nijland, K. Lam, D. de Jong
Journal: HemaSphere (2019)

Background: Central pathology review and translational studies on tissue biopsy material are an integral part of clinical trials for malignant lymphoma patients performed by HOVON (Haemato-Oncology Foundation for Adults in the Netherlands). However, in the past, obtaining biopsy samples has largely been dependent on individual efforts and thereby time consuming, expensive and incomplete, while material for translational research, if available, has not been consistently stored under optimal standard conditions. Aims: The HOVON Pathology Facility and Biobank (HOP) has built a professional logistic infrastructure and database for collection, processing, review and storage of biopsy samples of patients who are treated in HOVON lymphoma clinical trials in order to improve the quality and speed of pathology review and to optimally accommodate translational research. Methods We have newly developed and customized existing bio-informatics pipelines within the TraIT infrastructure. The HOP system is a cloud based solution to monitor requesting, dispatching, collecting and processing of bio-specimens. Privacy requirements, time constraints as well as legal permissions are documented. Once a patient is enrolled on a trial by the HOVON Datacenter the material is automatically requested from the original pathology laboratory by the HOP system. Upon receipt, the appropriate material is processed for pathology review (by 2 of 10 HOP-associated hematopathologists), TMA production, DNA/RNA extraction, including all the necessary additional assays for classification and/or (biomarker) stratification. The material is stored centrally at the HOP Facility for future (translational research) use and all remaining material is returned to the original pathology labs. All processes are logged in the HOP track & trace system. Results: HOP was opened as an operational facility in June 2015 and by January 2016 all 58 pathology laboratories in the Netherlands were contracted to contribute. Using a near “real time review”, turnaround time has been reduced dramatically and complete pathology review results are now available shortly after completion of targeted trial inclusion. E.g. for the HOVON130 trial (MYC+ DLBCL) all pathology results, including FISH data were available for a planned interim analysis 6 weeks after enrollment of the last patient and complete review was finalized with 100% review rate 2 months after the last inclusion allowing timely analysis of the primary clinical endpoint (ASH2018, abstract 786). Biopsy samples are readily available for translational research as demonstrated by a successful study on the prognostic impact of tumor microenvironment composition as evaluated with spectral imaging techniques in PCNSL patients treated in the HOVON 105 trial (manuscript in preparation). HOP biobanking and logistics enabled a multicenter study using next-generation sequencing, gene-expression and FISH analysis in biopsy samples of the HOVON84 trial (DLBCL) with integrated analysis on 250/600 enrolled patients (manuscript in preparation).Summary/Conclusion: The HOVON Pathology Facility and Biobank provides an efficient, transparent and quality controlled logistical process for handling requests, processing and returning of pathology material in clinical trials and has thus significantly improved the quality of pathology support of clinical trials. Moreover, the HOP system is designed to support and enable pre-inclusion biomarker-based clinical trials in the future whereas the biobanking facility enables successful translational research based on FAIR concepts (Findable, Accessible, Interoperable, Reusable).