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

Informazioni relative al progetto

TransBioLine

ID dell’accordo di sovvenzione: 821283

DOI

10.3030/821283

Progetto chiuso

Data della firma CE 8 Aprile 2019

Data di avvio 1 Febbraio 2019

Data di completamento 31 Gennaio 2025

Finanziato da

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Costo totale

€ 27 957 743,39

Contributo UE

€ 13 999 997,75

Coordinato da

UNIVERSITAT ZURICH
Switzerland

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

Documents, reports (7)

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.

Exploitation plan

Final report including the plans towards exploitation of the project.

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

Report on synergies with other initiatives

This deliverable will report on the relationships established to promote alignment and collaboration with other EU / international projects and initiatives.

SOP for sample collection, processing, storage, and shipment

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

Websites, patent fillings, videos etc. (1)

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.

Pubblicazioni

Peer reviewed articles (26)

Magnitude of Urine Albumin and KIM-1 Changes Can be Used to Differentiate Glomerular Injury From Tubular Injury in Rats

Autori: Yi-Zhong Gu, Erina Paul, Katerina Vlasakova, Sean P. Troth, Frank D. Sistare, Lila Ramaiah, Oliver Potz, Santosh Sutradhar, Warren E. Glaab
Pubblicato in: Toxicologic Pathology, Numero 52, 2025, Pagina/e 88-98, ISSN 0192-6233
Editore: SAGE Publications
DOI: 10.1177/01926233241248656

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

Autori: Jane I. Grove, Camilla Stephens, M Isabel Lucena, Raúl J Andrade, Sabine Weber, Alexander Gerbes et al.
Pubblicato in: Diagnostic and Prognostic Reserach, Numero 7, 2023, Pagina/e 18 (2023), ISSN 2397-7523
Editore: BMC
DOI: 10.1186/s41512-023-00155-z

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

Autori: 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
Pubblicato in: Cells, Numero 10, 2021, Pagina/e 1035, ISSN 2073-4409
Editore: MDPI
DOI: 10.3390/cells10051035

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

Autori: 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
Pubblicato in: Liver International, Numero 28, 2022, ISSN 1098-111X
Editore: Wiley Online Library
DOI: 10.1111/liv.15378

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

Autori: Atallah E, Freixo C, Alvarez-Alvarez I, Cubero F, Gerbes A, Kullak-Ublick G, Aithal G
Pubblicato in: Expert Opinion on Drug Metabolism & Toxicology, Numero 17 (11), 2021, Pagina/e 1327-1343, ISSN 1742-5255
Editore: 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.

Autori: 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
Pubblicato in: JHEP Reports, Numero 5, 2023, Pagina/e 1000851, ISSN 2589-5559
Editore: Elsevier
DOI: 10.1016/j.jhepr.2023.100851

Acute pancreatitis: diagnosis and treatment

Autori: Szatmary P, Grammatikopoulos T, Cai W, Huang W, Mukherjee R, Halloran C, Beyer G, Sutton R.
Pubblicato in: Drugs, Numero 82, 2022, Pagina/e 1251-1276, ISSN 1179-1950
Editore: Springer Nature
DOI: 10.1007/s40265-022-01766-4

Establishing reference ranges for circulating biomarkers of drug‐induced liver injury in healthy human volunteers¹

Autori: Andrea L. Jorgensen, Samantha Korver, Amy Schofield, Lawrence Howell, Joanna I. Clarke, Lauren E. Walker, Nathalie Brillant, Chris E. P. Goldring, Munir Pirmohamed
Pubblicato in: British Journal of Clinical Pharmacology, Numero 91, 2025, Pagina/e 1361-1369, ISSN 0306-5251
Editore: Blackwell Publishing Inc.
DOI: 10.1111/bcp.16371

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

Autori: 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
Pubblicato in: Journal of hepatology, Numero December 2022, 2023, ISSN 0168-8278
Editore: Elsevier BV
DOI: 10.1016/j.jhep.2022.12.034

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

Autori: Edmond Atallah, Pramudi Wijayasiri, Nicole Cianci, Khorrum Abdullah, Abhik Mukherjee, Guruprasad P. Aithal
Pubblicato in: BMC Gastroenterology, Numero 21/1, 2021, ISSN 1471-230X
Editore: 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.

Autori: 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
Pubblicato in: Nature /Scientific Reports, Numero 11, 2021, Pagina/e 23314, ISSN 2045-2322
Editore: 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

Autori: 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
Pubblicato in: Toxicological Sciences, 2021, ISSN 1096-6080
Editore: Oxford University Press
DOI: 10.1093/toxsci/kfab003

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

Autori: S Weber & AL Gerbes
Pubblicato in: International Journal of Molecular Sciences, Numero 23 (11), 2022, Pagina/e 6049, ISSN 1422-0067
Editore: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/ijms23116049

Association of cardiometabolic microRNAs with COVID-19 severity and mortality

Autori: 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
Pubblicato in: Cardiovascular research, Numero 114, 2022, Pagina/e 461-474, ISSN 0008-6363
Editore: 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

Autori: 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
Pubblicato in: Frontiers in Neuroscience, Numero 17, 2024, Pagina/e 2023, ISSN 1662-453X
Editore: The Journal of Neuroscience
DOI: 10.3389/fnins.2023.1285359

Chemotherapy-induced cognitive impairment and its long-term development in patients with breast cancer: results from the observational CICARO study

Autori: Anna Kerkmann, Christian Schinke, Adam Dordevic, Johannes Kern, Nikola Bangemann, Josefine Finck, Jens-Uwe Blohmer, Klemens Ruprecht, Jens C Göpfert, Carolin Otto, Bianca Materne, Matthias Endres, Wolfgang Boehmerle, Petra Huehnchen
Pubblicato in: The Oncologist, Numero 30, 2025, ISSN 1083-7159
Editore: AlphaMed Press Inc
DOI: 10.1093/oncolo/oyae268

Longitudinal evaluation of serum neurofilament light levels in normal healthy volunteers: defining a threshold of concern

Autori: Thomas A. Lanz, Klemens Ruprecht, Christopher J. Somps, Jens C. Göpfert, Tony Kam-Thong, Fetene Tekle, Kelly A. Fader, Viviana A. Carcamo Yañez, Volker Meyer, Sabine Friedrich, Katerina Vlasakova, Carolin Otto, Sara A. Paciga, Sophia L. Samodelov, Shashi K. Ramaiah
Pubblicato in: Journal of Neurology, Numero 272, 2025, ISSN 0340-5354
Editore: Dr. Dietrich Steinkopff Verlag
DOI: 10.1007/s00415-025-13246-2

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

Autori: Andreas Diendorfer,Kseniya Khamina,Marianne Pultar,Matthias Hackl
Pubblicato in: F1000Reserach, Numero 11, 2022, Pagina/e 233, ISSN 2046-1402
Editore: F1000 Research Ltd.
DOI: 10.12688/f1000research.94159.1

Drug‐Induced Liver Injury Associated With Emerging Cancer Therapies

Autori: Piotr Chodup, Sophia L. Samodelov, Michele Visentin, Gerd A. Kullak‐Ublick
Pubblicato in: Liver International, Numero 45, 2025, ISSN 1478-3223
Editore: Blackwell Publishing Inc.
DOI: 10.1111/liv.70002

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

Autori: 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
Pubblicato in: International Journal of Molecular Sciences, Numero 23, 2022, Pagina/e 1226, ISSN 1422-0067
Editore: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/ijms23031226

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

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

Neurofilament proteins as potential biomarker in chemotherapy-induced polyneuropathy

Autori: 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
Pubblicato in: JCI Insight, 2022, ISSN 2379-3708
Editore: 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

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

Systems analysis of miRNA biomarkers to inform drug safety

Autori: 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
Pubblicato in: Archives of Toxicology, 2021, ISSN 0340-5761
Editore: Springer Verlag
DOI: 10.1007/s00204-021-03150-9

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

Autori: Sheilabi M, Takeshita L, Sims E, Falciani F, Princivalle AP
Pubblicato in: Interantional Journal of Molecular Sciences, Numero 21, 2020, Pagina/e 2955, ISSN 1422-0067
Editore: 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

Autori: 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
Pubblicato in: Liver International, 2020, ISSN 1478-3223
Editore: Blackwell Publishing Inc.
DOI: 10.1111/liv.14713

Conference proceedings (1)

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

Autori: AlexanderL.Gerbes
Pubblicato in: Drug research, Numero S7, 2021, Pagina/e 71 (S 01), ISSN 2194-9387
Editore: Thieme
DOI: 10.1055/a-1606-5411

Monographic books (1)

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

Autori: Aithal GP, Andrade RJ, Björnsson ES, Kullak-Ublick GA, Lucena MI
Pubblicato in: CIOMS publication, 2020
Editore: CIOMS

Other (1)

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

Autori: Sabine Weber and Alexander L. Gerbes
Pubblicato in: Hepatobilliary Surgery and Nutrition, Numero 77, 2023, Pagina/e 1036-65, ISSN 2304-3881
Editore: AME publishing company
DOI: 10.21037/hbsn-23-329