Dataset Information

Cohort profile: Greifswald approach to individualized medicine (GANI_MED).

ABSTRACT:

Background

Individualized Medicine aims at providing optimal treatment for an individual patient at a given time based on his specific genetic and molecular characteristics. This requires excellent clinical stratification of patients as well as the availability of genomic data and biomarkers as prerequisites for the development of novel diagnostic tools and therapeutic strategies. The University Medicine Greifswald, Germany, has launched the "Greifswald Approach to Individualized Medicine" (GANI_MED) project to address major challenges of Individualized Medicine. Herein, we describe the implementation of the scientific and clinical infrastructure that allows future translation of findings relevant to Individualized Medicine into clinical practice.

Methods/design

Clinical patient cohorts (N?>?5,000) with an emphasis on metabolic and cardiovascular diseases are being established following a standardized protocol for the assessment of medical history, laboratory biomarkers, and the collection of various biosamples for bio-banking purposes. A multi-omics based biomarker assessment including genome-wide genotyping, transcriptome, metabolome, and proteome analyses complements the multi-level approach of GANI_MED. Comparisons with the general background population as characterized by our Study of Health in Pomerania (SHIP) are performed. A central data management structure has been implemented to capture and integrate all relevant clinical data for research purposes. Ethical research projects on informed consent procedures, reporting of incidental findings, and economic evaluations were launched in parallel.

SUBMITTER: Grabe HJ

PROVIDER: S-EPMC4040487 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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Publications

Cohort profile: Greifswald approach to individualized medicine (GANI_MED).

Grabe Hans J HJ Assel Heinrich H Bahls Thomas T Dörr Marcus M Endlich Karlhans K Endlich Nicole N Erdmann Pia P Ewert Ralf R Felix Stephan B SB Fiene Beate B Fischer Tobias T Flessa Steffen S Friedrich Nele N Gadebusch-Bondio Mariacarla M Salazar Manuela Gesell MG Hammer Elke E Haring Robin R Havemann Christoph C Hecker Michael M Hoffmann Wolfgang W Holtfreter Birte B Kacprowski Tim T Klein Kathleen K Kocher Thomas T Kock Holger H Krafczyk Janina J Kuhn Jana J Langanke Martin M Lendeckel Uwe U Lerch Markus M MM Lieb Wolfgang W Lorbeer Roberto R Mayerle Julia J Meissner Konrad K zu Schwabedissen Henriette Meyer HM Nauck Matthias M Ott Konrad K Rathmann Wolfgang W Rettig Rainer R Richardt Claudia C Saljé Karen K Schminke Ulf U Schulz Andrea A Schwab Matthias M Siegmund Werner W Stracke Sylvia S Suhre Karsten K Ueffing Marius M Ungerer Saskia S Völker Uwe U Völzke Henry H Wallaschofski Henri H Werner Vivian V Zygmunt Marek T MT Kroemer Heyo K HK

Journal of translational medicine 20140523

<h4>Background</h4>Individualized Medicine aims at providing optimal treatment for an individual patient at a given time based on his specific genetic and molecular characteristics. This requires excellent clinical stratification of patients as well as the availability of genomic data and biomarkers as prerequisites for the development of novel diagnostic tools and therapeutic strategies. The University Medicine Greifswald, Germany, has launched the "Greifswald Approach to Individualized Medicin ...[more]

PMID: 24886498

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Project description:PurposeResearch in acute care faces many challenges, including enrolment challenges, legal limitations in data sharing, limited funding and lack of singular ownership of the domain of acute care. To overcome these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data, image and biobank named 'Acutelines'.ParticipantsClinical data, imaging data and biomaterials (ie, blood, urine, faeces, hair) are collected from patients presenting to the emergency department (ED) with a broad range of acute disease presentations. A deferred consent procedure (by proxy) is in place to allow collecting data and biomaterials prior to obtaining written consent. The digital infrastructure used ensures automated capturing of all bed-side monitoring data (ie, vital parameters, electrophysiological waveforms) and securely importing data from other sources, such as the electronic health records of the hospital, ambulance and general practitioner, municipal registration and pharmacy. Data are collected from all included participants during the first 72 hours of their hospitalisation, while follow-up data are collected at 3 months, 1 year, 2 years and 5 years after their ED visit.Findings to dateEnrolment of the first participant occurred on 1 September 2020. During the first month, 653 participants were screened for eligibility, of which 180 were approached as potential participants. In total, 151 (84%) provided consent for participation of which 89 participants fulfilled criteria for collection of biomaterials.Future plansThe main aim of Acutelines is to facilitate research in acute medicine by providing the framework for novel studies and issuing data, images and biomaterials for future research. The protocol will be extended by connecting with central registries to obtain long-term follow-up data, for which we already request permission from the participant.Trial registration numberNCT04615065.

Project description:Background & aimsBiliary tract tumors are uncommon but highly aggressive malignancies with poor survival outcomes. Due to their low incidence, research into effective therapeutics has been limited. Novel research platforms for pre-clinical studies are desperately needed. We sought to develop a patient-derived biliary tract cancer xenograft catalog.MethodsWith appropriate consent and approval, surplus malignant tissues were obtained from surgical resection or radiographic biopsy and implanted into immunocompromised mice. Mice were monitored for xenograft growth. Established xenografts were verified by a hepatobiliary pathologist. Xenograft characteristics were correlated with original patient/tumor characteristics and oncologic outcomes. A subset of xenografts were then genomically characterized using Mate Pair sequencing (MPseq).ResultsBetween October 2013 and January 2018, 87 patients with histologically confirmed biliary tract carcinomas were enrolled. Of the 87 patients, 47 validated PDX models were successfully generated. The majority of the PDX models were created from surgical resection specimens (n = 44, 94%), which were more likely to successfully engraft when compared to radiologic biopsies (p = 0.03). Histologic recapitulation of original patient tumor morphology was observed in all xenografts. Successful engraftment was an independent predictor for worse recurrence-free survival. MPseq showed genetically diverse tumors with frequent alterations of CDKN2A, SMAD4, NRG1, TP53. Sequencing also identified worse survival in patients with tumors containing tetraploid genomes.ConclusionsThis is the largest series of biliary tract cancer xenografts reported to date. Histologic and genomic analysis of patient-derived xenografts demonstrates accurate recapitulation of original tumor morphology with direct correlations to patient outcomes. Successful development of biliary cancer tumografts is feasible and may be used to direct subsequent therapy in high recurrence risk patients.Lay summaryPatient biliary tract tumors grown in immunocompromised mice are an invaluable resource in the treatment of biliary tract cancers. They can be used to guide individualized cancer treatment in high-risk patients.

Dataset Information

Cohort profile: Greifswald approach to individualized medicine (GANI_MED).

Background

Methods/design

Publications

Cohort profile: Greifswald approach to individualized medicine (GANI_MED).

Similar Datasets

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