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Swiss Transplant Cohort Study

English title Swiss Transplant Cohort Study
Applicant Steiger Jürg Ulrich
Number 148512
Funding scheme Cohort Studies Large
Research institution Klinik für Transplantationsimmunologie und Nephrologie Universitätsspital
Institution of higher education University of Basel - BS
Main discipline Clinical Immunology and Immunopathology
Start/End 01.02.2014 - 31.01.2018
Approved amount 6'045'000.00
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All Disciplines (8)

Discipline
Clinical Immunology and Immunopathology
Occupational Medicine, Ergonomy
Methods of Epidemiology and Preventive Medicine
Clinical Pharmacology
Immunology, Immunopathology
Infectious Diseases
Clinical Cancer Research
Mental Disorders, Psychosomatic Diseases

Keywords (7)

Psycosocial; Transplantation; Infectious disease; Graft survival; Quality of life; Epidemiology; Immunology

Lay Summary (German)

Lead
Oft ist eine Organtransplantation die letzte Möglichkeit, Patienten mit terminalem Organversagen zu retten. Die Transplantationsmedizin hat in den letzten Jahre grosse Fortschritte gemacht, bleibt aber für Patienten und Ärzte eine grosse Herausforderung. Der Erfolg für das Individuum ist bestimmt durch das komplexe Zusammenspiel aus bio-medizinischen, psychosozialen und behandlungs-bezogenen Faktoren. Das Verständnis der Erfolgsfaktoren ist daher von grossem Interesse.
Lay summary

Die Schweizerische Transplantations Kohortenstudie (STCS)

Lead

Oft ist eine Organtransplantation die letzte Möglichkeit, Patienten mit terminalem Organversagen zu retten. Die Transplantationsmedizin hat in den letzten Jahre grosse Fortschritte gemacht, bleibt aber für Patienten und Ärzte eine grosse Herausforderung. Der Erfolg für das Individuum ist bestimmt durch das komplexe Zusammenspiel aus bio-medizinischen, psychosozialen und behandlungs-bezogenen Faktoren. Das Verständnis der Erfolgsfaktoren ist daher von grossem Interesse.

Inhalt und Ziel des Forschungsprojektes

Im Jahre 2007 haben Forscher aus verschiedenen Disziplinen die Schweizerische Transplantations Kohortenstudie (STCS) ins Leben gerufen. Die STCS ist eine Multizenterstudie, die für die Nachbeobachtung von Organempfängern in der Schweiz entwickelt wurde. Die Ziele der STCS sind, Forschung und Entwicklung im Bereich transplantationsbedingter Infektionskrankheiten, Genetik, Immunologie, Onkologie und psychosozialer Faktoren zu fördern. Zudem sollen Langzeitresultate veröffentlicht und internationalen verglichen werden. 

Seit Mai 2008 ist die STCS operativ tätig und hat bis Ende 2012 2122 Transplantatempfänger eingeschlossen und über 50 Forschungsprojekte gutgeheissen.

Wissenschaftlicher und gesellschaftlicher Kontext des Forschungsprojektes

In der Schweiz werden jährlich in 6 Zentren bis zu 400 Transplantationen durchgeführt. In den letzten Jahren hat sich die STCS als Forschungsinstrument in der hochspezialisierten und multidisziplinären Patientenversorgung etabliert. Ein Kernbestandteil sind Expertengremien, die laufend an der Harmonisierung der Versorgungskonzepte arbeiten. National und international profitieren Experten von Bio-Proben und qualitativ hochwertigen Daten für die patienten-zentrierte Forschung. Zudem macht das öffentliche Reporting der Transplantationsergebnisse die  Behandlungserfolge transparent. Es wird erwartet, dass dieser Schritt zusätzlich zu einer Verbesserung der Versorgungsqualität führt.   

Direct link to Lay Summary Last update: 27.01.2014

Lay Summary (French)

Lead
Pour de nombreux patients atteints de maladie d'organe terminale, la transplantation est la seule option pour améliorer la qualité de vie ou pour survivre. Malgré de nombreux progrès, la transplantation reste un défi pour la médecine. Sa réussite est déterminée par l'interaction complexe entre facteurs biomédicaux, psychosociaux et liés aux soins. Une meilleure compréhension des résultats post-transplantation est donc d’un grand intérêt.
Lay summary

La Cohorte Suisse de Transplantation (STCS)

Entête

Pour de nombreux patients atteints de maladie d'organe terminale, la transplantation est la seule option pour améliorer la qualité de vie ou pour survivre. Malgré de nombreux progrès, la transplantation reste un défi pour la médecine. Sa réussite est déterminée par l'interaction complexe entre facteurs biomédicaux, psychosociaux et liés aux soins. Une meilleure compréhension des résultats post-transplantation est donc d’un grand intérêt.

Objectif

En 2007, des chercheurs de différentes disciplines ont démarré l’étude de Cohorte Suisse de Transplantation (STCS), une étude multicentrique conçue pour suivre tous les receveurs d'organes en Suisse. La STCS a été créée pour favoriser de nouveaux développements dans les domaines des maladies infectieuses liées à la transplantation, des facteurs psychosociaux et génétiques, de l'immunologie et de l’oncologie. Les objectifs additionnels sont de suivre à long terme les résultats de la transplantation au niveau national, et de permettre une comparaison internationale.

De mai 2008 jusqu'à décembre 2012, 2122 patients transplantés ont été inclus dans la STCS et le comité scientifique a approuvé plus de 50 projets de recherche.

Contexte scientifique et sociétal du projet de recherche

En Suisse, entre 300 et 400 transplantations sont effectuées par an dans six centres. La médecine de transplantation est un domaine de soins multidisciplinaires complexes et spécialisés, utilisant beaucoup de ressources et nécessitant une recherche centrée sur le patient et une grande transparence. La STCS a évolué en modèle de recherche en médecine hautement spécialisée, unifiant les spécialistes afin d’harmoniser et optimiser les soins. Des investigateurs nationaux et internationaux bénéficient de la biobanque et des données cliniques pour la recherche. La publication des résultats a apporté de la transparence pour les patients transplantés en Suisse. Cette politique d'information ouverte devrait contribuer, entre autre, à l’amélioration de la qualité des soins.

 

 

Direct link to Lay Summary Last update: 27.01.2014

Lay Summary (English)

Lead
For many patients with end-stage organ diseases, transplantation is the only option for survival and to improve quality of life. Despite many advances, transplantation has remained one of the very challenging fields in modern medicine and the success of the individual is determined by the complex interplay of biomedical, psychosocial and care-related factors. Better understanding of post-transplantation outcome and improvement of quality of care are therefore of large interest.
Lay summary

The Swiss Transplant Cohort Study (STCS)

The Swiss Transplant Cohort Study (STCS)

The Swiss Transplant Cohort Study (STCS)

Lead

For many patients with end-stage organ diseases, transplantation is the only option for survival and to improve quality of life. Despite many advances, transplantation has remained one of the very challenging fields in modern medicine and the success of the individual is determined by the complex interplay of biomedical, psychosocial and care-related factors. Better understanding of post-transplantation outcome and improvement of quality of care are therefore of large interest.

Aim

In 2007, investigators from different disciplines launched the Swiss Transplant Cohort Study (STCS), a multicenter study designed to follow all organ recipients in Switzerland. The STCS was built to foster novel developments in the fields of transplant infectious diseases, psychosocial factors, genetics, immunology and oncology. Further aims are reporting of long-term outcome on the national level and to allow for international benchmarking.

From May 2008 until end of 2012, 2122 transplant patients were enrolled into the STCS and more than 50 scientific projects approved.

Scientific and societal context of the research project

In Switzerland, round 300-400 solid organ transplantations are performed per year in six transplant centers. Transplantation medicine is a multidisciplinary field of highly complex and resource-intensive patient care with a high need for patient-centered research and societal transparency. The STCS has evolved as a role model of research in highly specialized medicine and unified specialists to harmonize patient care. National and international experts benefit from the bio-bank and high-quality clinical data for science and development.  The reporting on patient-relevant outcomes has brought transparency into the Swiss transplant patient population and it is expected that this open information policy will additionally improve quality of care.

 

Direct link to Lay Summary Last update: 27.01.2014

Responsible applicant and co-applicants

Employees

Associated projects

Number Title Start Funding scheme
159523 Pseudomonas aeruginosa in lung transplant recipients: adaptation and competition in the new host environment 01.06.2015 Project funding (special)
137125 Return to Work: a long-term follow-up study after solid organ transplantation in Switzerland 01.09.2011 ProDoc
163369 Susceptibility for cutaneous squamous cell carcinoma in organ transplant recipients 01.01.2016 Project funding (special)
177522 Swiss Transplant Cohort Study 01.02.2018 Cohort Studies Large
165873 The novel human astroviruses: an emerging human infection that needs to be characterized at the epidemiological, clinical and virological levels 01.04.2016 Project funding (Div. I-III)
140929 Pseudomonas aeruginosa in lung transplant patients: adaptation, bacterial competition and novel therapeutic approaches 01.06.2012 Project funding (special)
140929 Pseudomonas aeruginosa in lung transplant patients: adaptation, bacterial competition and novel therapeutic approaches 01.06.2012 Project funding (special)
173545 Reducing the Burden of Influenza after Solid-Organ Transplantation: the STOP-FLU trial [Swiss Trial in Solid Organ Transplantation on Prevention of influenza] 01.06.2017 Investigator Initiated Clinical Trials (IICT)

Abstract

The Swiss Transplant Cohort Study (STCS) is a prospective open multisite cohort study of all organ transplant recipients in Switzerland. The STCS has a unique data structure that allows to display every transplant scenario and to monitor the complexity of patient care. Clinical and laboratory data as well as biological samples are collected at transplantation (baseline) and post transplantation at regular intervals. The full dataset includes demographic, organ specific, and immunological data, as well as infectious diseases complications, cancer occurrence and psychosocial aspects, all together allowing novel and high-quality research. The STCS also reports “minimal outcome” data to the Bundesamt für Gesundheit (Swiss Federal Health Office), to the Group of 15 (University Hospitals) and to the Swiss Highly Specialized Medicine Board. This minimal data however only represents 15% of the full STCS dataset.The STCS is primarily funded by the SNF and by all six Swiss transplant centers which provide the salaries for all the local database managers required to collect both the minimal and full datasets. During the first year of the SNF funding period (July 2007 to June 2008), the STCS established the infrastructure of the cohort, including an executive office, board of representatives, scientific committee, central and local data management structures and various working groups. Recently, a genetic platform has been created in view of the rapidly evolving issues in this field.In May 2008 the STCS enrolled its first patient and as of August 2012 included 1963 patients that underwent 2019 transplantations involving a total of 2118 implanted organs: 1116 single kidney, 389 liver, 192 lung, 142 heart, and 22 islets transplantations. To ensure data quality an external audit was performed in 2011/2012, detecting several problems, which were solved in version 2 and an adaptation of SOP’s.The scientific activities are controlled by the scientific committee. After a build-up phase, the STCS has recently entered in its scientifically productive phase. A total of 45 research projects have been submitted to the scientific committee, covering a wide scope from psychosocial aspects to infectious diseases, immunology and genetics. An article describing the design, methodology and psychosocial questionnaire evaluations of the STCS, two articles in the psychosocial field, one article describing the impact of enterococcal infections, as well as an article describing the relevance of cohort studies for transplant infectious diseases have recently been published. Moreover, a variety of original articles and abstracts have been submitted to peer-reviewed journals and were presented at international meetings. These include various studies on research domains such as patient adherence and compliance, invasive fungal infections, cytomegalovirus disease, heart transplantation or genetic polymorphisms and infectious-immunologic-metabolic outcomes after transplantation. Multicenter collaborations with other European cohorts, e.g. on infectious endpoints (Resitra) or on assessing the risk of chronic allograft dysfunction in lung transplant recipients (SysClad) have been launched and are currently under development. Results of the STCS have already directly impacted patient care by detecting an unusually high death rate in one heart transplant center, as well as an unexpected high incidence of Pneumocystis jirovecci infections in a kidney transplant centers. Thanks to the STCS, adequate measures could be implemented in both centers controlling the situation, thereby directly impacting patient survival.During the next four years (February 2014 to January 2018), in parallel to the continuing successful patient enrollment in the STCS, the main objective will be to increase the number and significance of approved scientific projects. The scientific committee will prioritize the implementation of epidemiologic and interventional studies, including translational research projects, which use bio bank stored sample material. Due to the increasing complexity and volume of the STCS enterprise, a core scientific infrastructure will be created to assist STCS scientists to plan, conduct and analyze projects nested in the cohort. The next funding period will also focus on systematic monitoring and improvement of data quality and into developing significant international collaborations. Future developments will also include an upgrade of the IT system to ensure longitudinal consistency of the data, enhancing data management and improving reporting. There are discussions to include patients in the reporting system and to provide the STCS participating clinicians with complex follow-up summaries. A close collaboration with the BAG has been established for data quality monitoring and an independent audit of the STCS was performed in 2011-2012.In conclusion, the STCS is a novel and comprehensive model for performing high quality transplant clinical, basic and translational research in a national multicenter collaborative cohort network. The STCS addresses current and future scientific challenges that the transplant community is facing and for which, to date, available research tools have been insufficient. Future progress in the field of transplantation will undoubtedly need new clinical and research endeavors such as the one represented by the STCS.
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