Translational Safety Biomarker Pipeline (TransBioLine): Enabling development and implementation of novel safety biomarkers in clinical trials and diagnosis of disease

Livrables

Data and Knowledge Management Plan (DMP)

The first DMP version will be available within 6 months, and constantly updated according to needs and progress of the Consortium. The DMP will take into account the guidelines for data security and personal data protection, according to the recommendation in the Code of Practice for Reuse of Medical Data in Scientific Research Projects developed in the eTRIKS Consortium, and the parameters of the ethical approval given for each study.

Project communication plan and initial toolset

A plan for dissemination that includes the communication objectives, target audiences, activities to be carried out and tools that will support their implementation, with connections among these components. It will also include an initial set of communication materials.

Design and set-up sample workflows

Definition of all procedures of biomaterial acquisition and processing, including ID-management.

Methodology, analysis of existing related initiatives, and tools for implementation

A roadmap of synergies with other projects/networks will be established, followed by implementation of the most relevant collaborations

SOP for sample collection, processing, storage, and shipment

Preparation of harmonized SOPs for sample collection, processing and shipment of samples.

Data repository for sample data

Patient data and analyses results will be handled by ITTM. The ZeBanC will store the samples with the corresponding data. For data storage, the LIMS system CentraXX is used. Both ITTM and the ZeBanC will coordinate data transfer or rather data linkage.

Publications

Study design for development of novel safety biomarkers of drug‑induced liver injury by the translational safety biomarker pipeline (TransBioLine) consortium: a study protocol for a nested case–control study

Auteurs: Jane I. Grove, Camilla Stephens, M Isabel Lucena, Raúl J Andrade, Sabine Weber, Alexander Gerbes et al.
Publié dans: Diagnostic and Prognostic Reserach, Numéro 7, 2023, Page(s) 18 (2023), ISSN 2397-7523
Éditeur: BMC
DOI: 10.1186/s41512-023-00155-z

Protective Effects of Necrostatin-1 in Acute Pancreatitis: Partial Involvement of Receptor Interacting Protein Kinase 1

Auteurs: Ouyang Y, Wen L, Armstrong J, Chvanov M, Latawiec D, Cai W, Awais M, Mukherjee R, Huang W, Gough P, Bertin J, Tepikin A, Sutton R, Criddle D
Publié dans: Cells, Numéro 10, 2021, Page(s) 1035, ISSN 2073-4409
Éditeur: MDPI
DOI: 10.3390/cells10051035

A new framework for advancing in drug-induced liver injury research. The Prospective European DILI Registry.

Auteurs: Björnsson ES, Stephens C, Atallah E, Robles-Diaz M, Alvarez-Alvarez I, Gerbes A, Weber S, Stirnimann G, Kullak-Ublick G, Cortez-Pinto H, Grove JI, Lucena MI, Andrade RJ, Aithal GP
Publié dans: Liver International, Numéro 28, 2022, ISSN 1098-111X
Éditeur: Wiley Online Library
DOI: 10.1111/liv.15378

Biomarkers of idiosyncratic drug-induced liver injury (DILI)-a systematic review

Auteurs: Atallah E, Freixo C, Alvarez-Alvarez I, Cubero F, Gerbes A, Kullak-Ublick G, Aithal G
Publié dans: Expert Opinion on Drug Metabolism & Toxicology, Numéro 17 (11), 2021, Page(s) 1327-1343, ISSN 1742-5255
Éditeur: Ashley Publications Ltd.
DOI: 10.1080/17425255.2021.1999410

Incidence, risk factors and outcomes of checkpoint inhibitor-induced liver injury: A 10-year real-world retrospective cohort study.

Auteurs: Atallah E, Welsh SJ, O'Carrigan B, Oshaughnessy A, Dolapo I, Kerr AS, Kucharczak J, Lee CYC, Crooks C, Hicks A, Chimakurthi CR, Rao A, Franks H, Patel PM, Aithal GP
Publié dans: JHEP Reports, Numéro 5, 2023, Page(s) 1000851, ISSN 2589-5559
Éditeur: Elsevier
DOI: 10.1016/j.jhepr.2023.100851

Acute pancreatitis: diagnosis and treatment

Auteurs: Szatmary P, Grammatikopoulos T, Cai W, Huang W, Mukherjee R, Halloran C, Beyer G, Sutton R.
Publié dans: Drugs, Numéro 82, 2022, Page(s) 1251-1276, ISSN 1179-1950
Éditeur: Springer Nature
DOI: 10.1007/s40265-022-01766-4

Risk of liver fibrosis associated with long-term methotrexate therapy may be overestimated

Auteurs: Edmond Atallah, Jane I. Grove, Colin Crooks, Esther Burden-Teh, Abhishek Abhishek, Sulleman Moreea, Kelsey M. Jordan, Aftab Ala, David Hutchinson, Richard J. Aspinall, Ruth Murphy, Guruprasad P. Aithal
Publié dans: Journal of hepatology, Numéro December 2022, 2023, ISSN 0168-8278
Éditeur: Elsevier BV
DOI: 10.1016/j.jhep.2022.12.034

Zanubrutinib-induced liver injury: a case report and literature review

Auteurs: Edmond Atallah, Pramudi Wijayasiri, Nicole Cianci, Khorrum Abdullah, Abhik Mukherjee, Guruprasad P. Aithal
Publié dans: BMC Gastroenterology, Numéro 21/1, 2021, ISSN 1471-230X
Éditeur: BioMed Central
DOI: 10.1186/s12876-021-01825-2

Genomics and transcriptomics landscapes associated to changes in insulin sensitivity in response to endurance exercise training.

Auteurs: Louise Y. Takeshita; Peter K. Davidsen; John Herbert; Philipp Antczak; Philipp Antczak; Matthijs K. C. Hesselink; Patrick Schrauwen; S. John Weisnagel; Jeremy M. Robbins; Robert E. Gerszten; Sujoy Ghosh; Mark A. Sarzynski; Claude Bouchard; Francesco Falciani
Publié dans: Nature /Scientific Reports, Numéro 11, 2021, Page(s) 23314, ISSN 2045-2322
Éditeur: Nature Publishing Group
DOI: 10.1038/s41598-021-98792-1

Evaluating the Sensitivity and Specificity of Promising Circulating Biomarkers to Diagnose Liver Injury in Humans

Auteurs: Heather P Llewellyn, Vishal S Vaidya, Zhenyu Wang, Qinghai Peng, Craig Hyde, David Potter, Jianying Wang, Qing Zong, Seda Arat, Matt Martin, Katherine Masek-Hammerman, Roscoe Warner, Kent Johnson, Gerd A Kullak-Ublick, Guruprasad P Aithal, James W Dear, Shashi K Ramaiah
Publié dans: Toxicological Sciences, 2021, ISSN 1096-6080
Éditeur: Oxford University Press
DOI: 10.1093/toxsci/kfab003

Challenges and Future of Drug-Induced Liver Injury Research - Laboratory Tests

Auteurs: S Weber & AL Gerbes
Publié dans: International Journal of Molecular Sciences, Numéro 23 (11), 2022, Page(s) 6049, ISSN 1422-0067
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/ijms23116049

Association of cardiometabolic microRNAs with COVID-19 severity and mortality

Auteurs: Clemens Gutmann, Kseniya Khamina, Konstantinos Theofilatos, Andreas B. Diendorfer, Sean A. Burnap, Adam Nabeebaccus, Matthew Fish, Mark J.W. McPhail, Kevin O’Gallagher, Lukas E. Schmidt, Christian Cassel, Georg Auzinger, Salvatore Napoli, Salma F. Mujib, Francesca Trovato, Barnaby Sanderson, Blair Merrick, Roman Roy, Jonathan D. Edgeworth, Ajay M. Shah, Adrian C. Hayday, Ludwig Traby, Matthias H
Publié dans: Cardiovascular research, Numéro 114, 2022, Page(s) 461-474, ISSN 0008-6363
Éditeur: Elsevier BV
DOI: 10.1093/cvr/cvab338

Performance of biomarkers NF-L, NSE, Tau and GFAP in blood ans cerebrospinal fluid in rat for the detection of nervous system injury

Auteurs: Katerina Vlasakova, Takayuki Tsuchiya, Ivy N. Garfinkel, Michael P. Ruth, Cheryl Tyszkiewicz, Theodore J. Detwiler, Christopher J. Somps , Lorenzo Di Cesare Mannelli and Warren E. Glaab
Publié dans: Frontiers in Neuroscience, Numéro 17, 2024, Page(s) 2023, ISSN 1662-453X
Éditeur: The Journal of Neuroscience
DOI: 10.3389/fnins.2023.1285359

miND (miRNA NGS Discovery pipeline): a small RNA-seq analysis pipeline and report generator for microRNA biomarker discovery studies

Auteurs: Andreas Diendorfer,Kseniya Khamina,Marianne Pultar,Matthias Hackl
Publié dans: F1000Reserach, Numéro 11, 2022, Page(s) 233, ISSN 2046-1402
Éditeur: F1000 Research Ltd.
DOI: 10.12688/f1000research.94159.1

A MicroRNA Next-Generation-Sequencing Discovery Assay (miND) for Genome-Scale Analysis and Absolute Quantitation of Circulating MicroRNA Biomarkers

Auteurs: Kseniya Khamina, Andreas B. Diendorfer, Susanna Skalicky, Moritz Weigl, Marianne Pultar,Teresa L. Krammer, Catharine Aquino Fournier, Amy L. Schofield, Carolin Otto, Aaron Thomas Smith, Nina Buchtele, Christian Schoergenhofer, Bernd Jilma, Bernhard J. H. Frank, Jochen G. Hofstaetter, Regina Grillari, Johannes Grillari, Klemens Ruprecht, Christopher E. Goldring, Hubert Rehrauer, Warren E. Glaab and
Publié dans: International Journal of Molecular Sciences, Numéro 23, 2022, Page(s) 1226, ISSN 1422-0067
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/ijms23031226

Plasma Sphingoid Base Profiles of Patients Diagnosed with Intrinsic or Idiosyncratic Drug-induced Liver Injury.

Auteurs: Zhibo Gai, Sophia L. Samodelov, Irina Alecu, Thorsten Hornemann, Jane I. Grove, Guruprasad P. Aithal, Michele Visentin and Gerd A. Kullak-Ublick
Publié dans: International Journal of Molecular Sciences, Numéro 24 (3), 2023, ISSN 1422-0067
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/ijms24033013

Neurofilament proteins as potential biomarker in chemotherapy-induced polyneuropathy

Auteurs: Huehnchen P, Schinke C, Bangemann N, Dordevic A, Kern J, Maierhof S, Hew L, Nolte L, Körtvelyessy P, Göpfert J, Ruprecht K, Somps C, Blohmer J, Sehouli J, Endres M, Boehmerle W
Publié dans: JCI Insight, 2022, ISSN 2379-3708
Éditeur: American Society for Clinical Investigation
DOI: 10.1172/jci.insight.154395

Plasma Biomarkers TAP, CPA1, and CPA2 for the Detection of Pancreatic Injury in Rat: The development of a Novel Multiplex IA-LC-MS/MS Assay and Biomarker Performance Evaluation

Auteurs: Katerina Vlasakova, Andreas Steinhilber, Wendy J. Bailey, Zoltan Erdos, Hanna Haag, Thomas Joos, Bradley L. Ackermann, Oliver Poetz & Warren E. Glaab
Publié dans: Archives of Toxicology, 2022, ISSN 1944-4036
Éditeur: Springer
DOI: 10.1007/s00204-022-03425-9

Systems analysis of miRNA biomarkers to inform drug safety

Auteurs: Amy L. Schofield, Joseph P. Brown, Jack Brown, Ania Wilczynska, Catherine Bell, Warren E. Glaab, Matthias Hackl, Lawrence Howell, Stephen Lee, James W. Dear, Mika Remes, Paul Reeves, Eunice Zhang, Jens Allmer, Alan Norris, Francesco Falciani, Louise Y. Takeshita, Shiva Seyed Forootan, Robert Sutton, B. Kevin Park, Chris Goldring
Publié dans: Archives of Toxicology, 2021, ISSN 0340-5761
Éditeur: Springer Verlag
DOI: 10.1007/s00204-021-03150-9

The Sodium Channel B4-Subunits are Dysregulated in Temporal Lobe Epilepsy Drug-Resistant Patients

Auteurs: Sheilabi M, Takeshita L, Sims E, Falciani F, Princivalle AP
Publié dans: Interantional Journal of Molecular Sciences, Numéro 21, 2020, Page(s) 2955, ISSN 1422-0067
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/ijms21082955

Incidence and prevalence of acute hepatitis E virus infection in patients with suspected Drug‐Induced Liver Injury in the Spanish DILI Registry

Auteurs: Judith Sanabria‐Cabrera, Rocío Sanjuán‐Jiménez, Encarnación Clavijo, Inmaculada Medina‐Cáliz, Andrés González‐Jiménez, Miren García‐Cortés, Aida Ortega‐Alonso, Miguel Jiménez‐Pérez, Rocío González‐Grande, Camilla Stephens, Mercedes Robles‐Díaz, M Isabel Lucena, Raúl J. Andrade
Publié dans: Liver International, 2020, ISSN 1478-3223
Éditeur: Blackwell Publishing Inc.
DOI: 10.1111/liv.14713

Drug-Induced Liver Injury (DILI): A Major Challenge

Auteurs: AlexanderL.Gerbes
Publié dans: Drug research, Numéro S7, 2021, Page(s) 71 (S 01), ISSN 2194-9387
Éditeur: Thieme
DOI: 10.1055/a-1606-5411

Drug-induced liver injury (DILI): Current status and future directions for drug development and the post-market setting. A consensus by a CIOMS Working Group

Auteurs: Aithal GP, Andrade RJ, Björnsson ES, Kullak-Ublick GA, Lucena MI
Publié dans: CIOMS publication, 2020
Éditeur: CIOMS

Update on herbal and dietary supplement-induced liver injury: current gaps and future directions

Auteurs: Sabine Weber and Alexander L. Gerbes
Publié dans: Hepatobilliary Surgery and Nutrition, Numéro 77, 2023, Page(s) 1036-65, ISSN 2304-3881
Éditeur: AME publishing company
DOI: 10.21037/hbsn-23-329

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