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

Rezultaty

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.

Publikacje

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

Autorzy: Jane I. Grove, Camilla Stephens, M Isabel Lucena, Raúl J Andrade, Sabine Weber, Alexander Gerbes et al.
Opublikowane w: Diagnostic and Prognostic Reserach, Numer 7, 2023, Strona(/y) 18 (2023), ISSN 2397-7523
Wydawca: BMC
DOI: 10.1186/s41512-023-00155-z

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

Autorzy: 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
Opublikowane w: Cells, Numer 10, 2021, Strona(/y) 1035, ISSN 2073-4409
Wydawca: MDPI
DOI: 10.3390/cells10051035

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

Autorzy: 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
Opublikowane w: Liver International, Numer 28, 2022, ISSN 1098-111X
Wydawca: Wiley Online Library
DOI: 10.1111/liv.15378

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

Autorzy: Atallah E, Freixo C, Alvarez-Alvarez I, Cubero F, Gerbes A, Kullak-Ublick G, Aithal G
Opublikowane w: Expert Opinion on Drug Metabolism & Toxicology, Numer 17 (11), 2021, Strona(/y) 1327-1343, ISSN 1742-5255
Wydawca: 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.

Autorzy: 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
Opublikowane w: JHEP Reports, Numer 5, 2023, Strona(/y) 1000851, ISSN 2589-5559
Wydawca: Elsevier
DOI: 10.1016/j.jhepr.2023.100851

Acute pancreatitis: diagnosis and treatment

Autorzy: Szatmary P, Grammatikopoulos T, Cai W, Huang W, Mukherjee R, Halloran C, Beyer G, Sutton R.
Opublikowane w: Drugs, Numer 82, 2022, Strona(/y) 1251-1276, ISSN 1179-1950
Wydawca: Springer Nature
DOI: 10.1007/s40265-022-01766-4

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

Autorzy: 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
Opublikowane w: Journal of hepatology, Numer December 2022, 2023, ISSN 0168-8278
Wydawca: Elsevier BV
DOI: 10.1016/j.jhep.2022.12.034

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

Autorzy: Edmond Atallah, Pramudi Wijayasiri, Nicole Cianci, Khorrum Abdullah, Abhik Mukherjee, Guruprasad P. Aithal
Opublikowane w: BMC Gastroenterology, Numer 21/1, 2021, ISSN 1471-230X
Wydawca: 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.

Autorzy: 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
Opublikowane w: Nature /Scientific Reports, Numer 11, 2021, Strona(/y) 23314, ISSN 2045-2322
Wydawca: 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

Autorzy: 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
Opublikowane w: Toxicological Sciences, 2021, ISSN 1096-6080
Wydawca: Oxford University Press
DOI: 10.1093/toxsci/kfab003

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

Autorzy: S Weber & AL Gerbes
Opublikowane w: International Journal of Molecular Sciences, Numer 23 (11), 2022, Strona(/y) 6049, ISSN 1422-0067
Wydawca: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/ijms23116049

Association of cardiometabolic microRNAs with COVID-19 severity and mortality

Autorzy: 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
Opublikowane w: Cardiovascular research, Numer 114, 2022, Strona(/y) 461-474, ISSN 0008-6363
Wydawca: 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

Autorzy: 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
Opublikowane w: Frontiers in Neuroscience, Numer 17, 2024, Strona(/y) 2023, ISSN 1662-453X
Wydawca: 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

Autorzy: Andreas Diendorfer,Kseniya Khamina,Marianne Pultar,Matthias Hackl
Opublikowane w: F1000Reserach, Numer 11, 2022, Strona(/y) 233, ISSN 2046-1402
Wydawca: 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

Autorzy: 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
Opublikowane w: International Journal of Molecular Sciences, Numer 23, 2022, Strona(/y) 1226, ISSN 1422-0067
Wydawca: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/ijms23031226

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

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

Neurofilament proteins as potential biomarker in chemotherapy-induced polyneuropathy

Autorzy: 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
Opublikowane w: JCI Insight, 2022, ISSN 2379-3708
Wydawca: 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

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

Systems analysis of miRNA biomarkers to inform drug safety

Autorzy: 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
Opublikowane w: Archives of Toxicology, 2021, ISSN 0340-5761
Wydawca: Springer Verlag
DOI: 10.1007/s00204-021-03150-9

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

Autorzy: Sheilabi M, Takeshita L, Sims E, Falciani F, Princivalle AP
Opublikowane w: Interantional Journal of Molecular Sciences, Numer 21, 2020, Strona(/y) 2955, ISSN 1422-0067
Wydawca: 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

Autorzy: 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
Opublikowane w: Liver International, 2020, ISSN 1478-3223
Wydawca: Blackwell Publishing Inc.
DOI: 10.1111/liv.14713

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

Autorzy: AlexanderL.Gerbes
Opublikowane w: Drug research, Numer S7, 2021, Strona(/y) 71 (S 01), ISSN 2194-9387
Wydawca: 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

Autorzy: Aithal GP, Andrade RJ, Björnsson ES, Kullak-Ublick GA, Lucena MI
Opublikowane w: CIOMS publication, 2020
Wydawca: CIOMS

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

Autorzy: Sabine Weber and Alexander L. Gerbes
Opublikowane w: Hepatobilliary Surgery and Nutrition, Numer 77, 2023, Strona(/y) 1036-65, ISSN 2304-3881
Wydawca: AME publishing company
DOI: 10.21037/hbsn-23-329

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