Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500000 participants
OBSERVATIONAL
2018-01-01
2071-01-31
Brief Summary
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Detailed Description
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The cantonal Ethics Committee of Bern approved the SRDR project (project ID: 2017-02313, observational study, risk category A).
Objectives: The overall goal of the SRDR is to improve the care situation of people living with a rare disease in Switzerland. The development of a national registry to collect representative and complete data from children and adults with a rare disease in Switzerland helps to achieve this overall goal.
Primary objectives of the SRDR project:
1. Collect epidemiological data on rare diseases from all patients with rare diseases in Switzerland (incidence, prevalence, survival, mortality).
2. Collect data on quality of health care and outcomes (diagnosis, management, outcomes, quality indicators, treating institutions).
3. Setup a research platform for clinical, epidemiological, basic, and translational research on all rare diseases.
4. Facilitate patients to participate in national and international studies.
5. Promote harmonisation of data and methods between the numerous existing disease-specific registries in Switzerland.
6. Strengthen exchange with international rare disease registries for research and policy.
7. Build a network for communication, for patients and health care providers.
Procedure: After a person has been diagnosed with a rare disease, the medical staff inform the patient and/or the legal representative orally about the SRDR and its purpose during regular consultation. The medical staff will hand over the written age-appropriate patient information and the informed consent form. Patient organizations and the staff from the SRDR also have the possibility to inform people about the SRDR. Further, patients have the possibility to use a secure web-based application for self-notification.
The patient or/and the legal representative have 6 weeks to give or refuse the informed consent. Patients who wish to participate sign the consent form and are then registered in the SRDR. If a patient or/and legal representative do neither refuse registration nor sign informed consent within 6 weeks, the data will be registered. If a patient does not wish to participate, only a minimal anonymous data set is recorded.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient population
Children, adolescents, and adults with a high suspicion, or a confirmed diagnosis of a rare disease who are treated or living in Switzerland.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* High suspicion of a rare disease
* Treated or living in Switzerland
* Signed informed consent
Exclusion Criteria
ALL
No
Sponsors
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Federal Office of Public Health, Switzerland
OTHER_GOV
Universitäts-Kinderspital Zürich
UNKNOWN
University Children's Hospital Basel
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
University Hospital, Zürich
OTHER
Centre Hospitalier Universitaire Vaudois
OTHER
University Hospital, Geneva
OTHER
Proraris Allianz seltener Krankheiten
UNKNOWN
Kosek National Coordination Rare Diseases Switzerland
UNKNOWN
Orphanet Suisse
UNKNOWN
University of Zurich
OTHER
Kantonsspital Aarau
OTHER
Ente Ospedaliero Cantonale, Bellinzona
OTHER
Cantonal Hospital of St. Gallen
OTHER
Ostschweizer Kinderspital
OTHER
University Hospital, Basel, Switzerland
OTHER
Balgrist University Hospital
OTHER
Centro Malattie Rare della Svizzera Italiana
UNKNOWN
University of Bern
OTHER
Responsible Party
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Principal Investigators
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Claudia E Kuehni, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Social and Preventive Medicine (ISPM)
Locations
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Kantonsspital Aarau, Pädiatrie
Aarau, , Switzerland
Kantonsspital Aarau
Aarau, , Switzerland
Center for Rare Diseases, Basel
Basel, , Switzerland
Universitäs-Kinderspital beider Basel, UKBB
Basel, , Switzerland
Universitätsspital Basel, USB
Basel, , Switzerland
Centro Malattie Rare della Svizzera Italiana
Bellinzona, , Switzerland
Center for Rare Diseases, Inselspital
Bern, , Switzerland
University of Bern, Inselspital Bern
Bern, , Switzerland
Center for Rare Diseases, Geneva
Geneva, , Switzerland
Hôpitaux universitaires de Genève, HUG
Geneva, , Switzerland
Center for Rare Diseases, Lausanne
Lausanne, , Switzerland
Centre hospitalier universitaire vaudois, CHUV
Lausanne, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Ostschweizer Kinderspital
Sankt Gallen, , Switzerland
Ostschweizer Zentrum für seltene Krankheiten, Pädiatrie
Sankt Gallen, , Switzerland
Ostschweizer Zentrum für seltene Krankheiten
Sankt Gallen, , Switzerland
Center for Rare Diseases, Zurich
Zurich, , Switzerland
Universitäts-Kinderspital Zürich, Kispi
Zurich, , Switzerland
Universitätsklinik Balgrist
Zurich, , Switzerland
Universitätsspital Zürich, USZ
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Henrik Kähler, Prof.
Role: primary
Beat Müller, Prof.
Role: primary
Andreas Wörner, Dr.med.
Role: primary
Andreas Wörner, Dr.med.
Role: primary
Mike Recher, Prof.
Role: primary
Colette Balice-Bourgois, PhD
Role: primary
Jean-Marc Nuoffer, Prof.
Role: primary
Jean-Marc Nuoffer, Prof.
Role: primary
Loredana D'Amato Sizonenko, Dr.med.
Role: primary
Loredana D' Amato Sizonenko, Dr.med.
Role: primary
Alessandra Strom, PhD
Role: primary
Alessandra Strom, PhD
Role: primary
Stefan Bilz, PD Dr.
Role: primary
Dagmar L'Allemand, Prof.
Role: primary
Dagmar L'Allemand, Prof.
Role: primary
Stefan Bilz, Dr.med.
Role: primary
Corinne Rueegger, Dr.med.
Role: primary
Corinne Rueegger, Dr.med.
Role: primary
Madlaina Schöni, Dr.med.
Role: primary
Corinne Rueegger, Dr.med,
Role: primary
Other Identifiers
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2017-02313
Identifier Type: -
Identifier Source: org_study_id
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