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NCT05179863 | RECRUITING | Rare Diseases


Swiss Rare Disease Registry (SRDR)
Sponsor:

University of Bern

Brief Summary:

The SRDR is a national registry that records rare diseases in people of any age who live in Switzerland. It serves as a platform for scientists, health professionals, affected people, and politicians.The SRDR aims to collect epidemiological data on rare diseases, and data on changes to the diagnosis over time. The SRDR will further serve as a research platform and facilitate patient participation in national and international studies. The SRDR will promote harmonization of data and method between the numerous existing disease-specific registries in Switzerland, will strengthen the exchange with international rare disease registries for research and policy, and will build a network for communication for patients and health care providers.

Condition or disease

Rare Diseases

Detailed Description:

Background: In Europe a disease is considered rare when fewer than one in 2'000 people are affected. Today, more than 7'000 rare diseases are known. Although scarce, rare diseases all together affect approximately 5-8% of the people around the world. In Switzerland, more than 500'000 people live with a rare disease. Clinical and epidemiological studies on rare diseases in Switzerland are lacking. Little is known about diagnostics, efficient treatment, and the course of rare diseases. 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 500000 participants
Official Title : Swiss Rare Disease Registry
Actual Study Start Date : 2018-01-01
Estimated Primary Completion Date : 2071-01
Estimated Study Completion Date : 2071-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Diagnosed with a rare disease
  • * High suspicion of a rare disease
  • * Treated or living in Switzerland
  • * Signed informed consent
Exclusion Criteria
  • * None

Swiss Rare Disease Registry (SRDR)

Location Details

NCT05179863


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

Switzerland,

Aarau Cantonal Hospital, pediatrics

Aarau, Switzerland,

RECRUITING

Switzerland,

Aarau Cantonal Hospital

Aarau, Switzerland,

NOT YET RECRUITING

Switzerland,

Center for Rare Diseases, Basel

Basel, Switzerland,

NOT YET RECRUITING

Switzerland,

University Children's Hospital of Basel, UKBB

Basel, Switzerland,

NOT YET RECRUITING

Switzerland,

University Hospital Basel, USB

Basel, Switzerland,

RECRUITING

Switzerland,

Rare Disease Center of Italian Switzerland

Bellinzona, Switzerland,

RECRUITING

Switzerland,

Center for Rare Diseases, Inselspital

Bern, Switzerland,

RECRUITING

Switzerland,

University of Bern, Inselspital Bern

Bern, Switzerland,

RECRUITING

Switzerland,

Center for Rare Diseases, Geneva

Geneva, Switzerland,

RECRUITING

Switzerland,

Geneva University Hospitals, HUG

Geneva, Switzerland,

RECRUITING

Switzerland,

Center for Rare Diseases, Lausanne

Lausanne, Switzerland,

RECRUITING

Switzerland,

Vaud university hospital center, CHUV

Lausanne, Switzerland,

NOT YET RECRUITING

Switzerland,

St. Gallen Cantonal Hospital

Saint Gallen, Switzerland,

NOT YET RECRUITING

Switzerland,

Eastern Swiss children's hospital

Saint Gallen, Switzerland,

NOT YET RECRUITING

Switzerland,

Eastern Swiss Center for Rare Diseases, Pediatrics

Saint Gallen, Switzerland,

NOT YET RECRUITING

Switzerland,

Eastern Swiss Center for Rare Diseases

Saint Gallen, Switzerland,

NOT YET RECRUITING

Switzerland,

Center for Rare Diseases, Zurich

Zurich, Switzerland,

RECRUITING

Switzerland,

University Children's Hospital Zurich, Kispi

Zurich, Switzerland,

NOT YET RECRUITING

Switzerland,

Balgrist University Hospital

Zurich, Switzerland,

NOT YET RECRUITING

Switzerland,

University Hospital Zurich, USZ

Zurich, Switzerland,

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