Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06213402
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2023-12-04
Brief Title:
RADeep Multicenter European Epidemiological Platform for Patients Diagnosed With Rare Anemia Disorders RADs
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
A RetrospectiveProspective Multicenter European Epidemiological Platform for Patients Diagnosed With Rare Anemia Disorders RADs With Clinical Significance
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADeep
Brief Summary:
Rare Anaemia Disorders RADs is a group of rare diseases characterized for presenting anaemia as the main clinical manifestation Different medical entities classified as RADs by ORPHA classification are most of them chronic life threating disorders with many unmet needs for their proper clinical management creating an impact on European health systems RADs present diagnostic challenges and their appropriate management requires from specialised multidisciplinary teams in Centers of expertise
Although there are some examples of well-established national registries on RADs in EU the lack of recommendations for Rare disease registries implementation and the lack of standards for interoperability has led to the fragmentation or unavailability of data on prevalence survival main clinical manifestations or treatments in most of the European countries
Although there are some examples of well-established national registries on RADs in EU the lack of recommendations for Rare disease registries implementation and the lack of standards for interoperability has led to the fragmentation or unavailability of data on prevalence survival main clinical manifestations or treatments in most of the European countries
Detailed Description:
The Rare Anaemia Disorders European Epidemiological Platform RADeep is an initiative endorsed by the European Reference Network on Rare Hematological Diseases ERN-EuroBloodNet under the frame of the European Blood Disorders Platform ENROL the ERN-EuroBloodNet umbrella platform officially endorsed by the European Hematology Association EHA for European patients registries on rare haematological diseases RADeep will share pseudonymised level data with ENROL
RADeep supports the standardized collection of data of patients affected by any RADs at the European level maximizing public benefit from data on RADs opened-up with the only restriction needed to guarantee patient rights and confidentiality in agreement with the General Data Protection Regulation and applicable laws for cross-border sharing of personal data RADeep has the following major objectives
1 To collect and describe the demographics disease-management and treatment outcomes of patients diagnosed with RADs
2 To perform observational studies concerning research questions and to present outcomes in the fields of health related to organ damage and risk stratification for identification of trial cohorts for new drugs andor development of research projects
3 To promote harmonization and best practices in the prevention diagnosis treatment and follow-up of RADs patients by the dissemination of reliable Guidelines and the translation of research results into clinical practice
RADeep supports the standardized collection of data of patients affected by any RADs at the European level maximizing public benefit from data on RADs opened-up with the only restriction needed to guarantee patient rights and confidentiality in agreement with the General Data Protection Regulation and applicable laws for cross-border sharing of personal data RADeep has the following major objectives
1 To collect and describe the demographics disease-management and treatment outcomes of patients diagnosed with RADs
2 To perform observational studies concerning research questions and to present outcomes in the fields of health related to organ damage and risk stratification for identification of trial cohorts for new drugs andor development of research projects
3 To promote harmonization and best practices in the prevention diagnosis treatment and follow-up of RADs patients by the dissemination of reliable Guidelines and the translation of research results into clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None