Status:
RECRUITING
Integrative Diagnosis for SCD and Other RADs
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Hospital Clinic de Barcelona, Barcelona, Spain
Institute for Bioengineering of Catalonia
Conditions:
Sickle Cell Disease
Thalassaemia
Eligibility:
All Genders
Brief Summary
INTEGRA aims at enabling personalized medicine for RHADs patients by the establishment of an integrative diagnostic approach based on deep phenotypic and genetic characterization through combining new...
Detailed Description
Objectives: * To assess the prognostic value of LoRRca (ektacytometry) as biomarker providing information of SCD/RADs patients severity * To investigate the correlation between LoRRca parameters and ...
Eligibility Criteria
Inclusion
- Patients sustaining a confirmed or suspected diagnosis of an hereditary rare hemolytic anemia:
- Sickle cell disease
- Thalassemic syndromes
- Congenital dyserythropoietic anemia
- Enzymopathy
- Unstable Hemoblogin / Altered oxygen affinity
- Hereditary stomatocytosis
- Hereditary pyropoikilocytosis
- Hereditary spherocytosis with severe anemia (\<8 g/dL) or inconclusive diagnosis:
- Patient with chronic hemolytic anemia and red cell smear compatible, but with:
- EMA binding test: inconclusive or negative
- Genetic testing: no definitive diagnosis (VUS or no findings)
- Not transplanted or undergoing gene therapy at the time of inclusion. Patients with graft failure without a new transplant may be included.
Exclusion
- Carrier traits in autosomal recessive hereditary anemias
Key Trial Info
Start Date :
November 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07206095
Start Date
November 13 2020
End Date
May 1 2028
Last Update
October 3 2025
Active Locations (9)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08025
2
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
3
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain, 08950
4
Hospital General de Granollers
Granollers, Barcelona, Spain, 08402