NCT06250595 European Rare Blood Disorders Platform (ENROL)
| NCT ID | NCT06250595 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Condition | Anemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 37,090 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2037-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 37,090 participants in total. It began in 2022-07-01 with a primary completion date of 2037-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
ENROL, the European Rare Blood Disorders Platform has been conceived in the core of ERN-EuroBloodNet as an umbrella for both new and already existing registries on Rare Hematological Diseases (RHDs). ENROL aims at avoiding fragmentation of data by promoting the standards for patient registries' interoperability released by the EU RD platform. ENROL's principle is to maximize public benefit from data on RHDs opened up through the platform with the only restriction needed to guarantee patient rights and confidentiality, in agreement with EU regulations for cross-border sharing of personal data. Accordingly, ENROL will map the EU-level demographics, survival rates, diagnosis methods, genetic information, main clinical manifestations, and treatments in order to obtain epidemiological figures and identify trial cohorts for basic and clinical research. To this aim, ENROL will connect and facilitate the upgrading of existing RHD registries, while promoting the building of new ones when / where lacking. Target-driven actions will be carried out in collaboration with EURORDIS for educating patients and families about the benefits of enrolment in such registries, including different cultural and linguistic strategies. The standardized collection and monitoring of disease-specific healthcare outcomes through the ENROL user-friendly platform will determine how specialized care is delivered, where are the gaps in diagnosis, care, or treatment and where best to allocate financial, technical, or human resources. Moreover, it will allow for promoting research, especially for those issues that remain unanswered or sub-optimally addressed by the scientific community; furthermore, it will allow promoting clinical trials for new drugs. ENROL will enable the generation of evidence for better healthcare for RHD patients in the EU as the ultimate goal. ENROL officially started on 1st June 2020 with a duration of 36 months. ENROL is co-funded by the Health Programme of the European Union under the call for proposals HP-PJ-2019 on Rare disease registries for the European Reference Networks. GA number 947670
Eligibility Criteria
Inclusion Criteria: * Patients must meet all of the following criteria to be included in the ENROL Registry * Age from 0-100, both female and male * Diagnosed as RHDs according to ORPHANET classification * Able and willing to provide written informed consent (patient or legal representative for minors) if needed according to national legislation. Exclusion Criteria: * Patients diagnosed as traits or trait conditions for other recessive RHDs
Contact & Investigator
María del Mar Manú Pereira, PhD
PRINCIPAL INVESTIGATOR
Vall d'Hebron Institut de Recerca / University Hospital Vall d'Hebron (VHIR / HUVH)
Frequently Asked Questions
Who can join the NCT06250595 clinical trial?
This trial is open to participants of all sexes, up to 100 Years, studying Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06250595 currently recruiting?
Yes, NCT06250595 is actively recruiting participants. Contact the research team at mar.manu@vhir.org for enrollment information.
Where is the NCT06250595 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06250595 clinical trial?
NCT06250595 is sponsored by Hospital Universitari Vall d'Hebron Research Institute. The principal investigator is María del Mar Manú Pereira, PhD at Vall d'Hebron Institut de Recerca / University Hospital Vall d'Hebron (VHIR / HUVH). The trial plans to enroll 37,090 participants.