Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-30 @ 11:32 AM
Study NCT ID:
NCT07206095
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrative Diagnosis for SCD and Other RADs
Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Organization:
Study Overview
Official Title:
Integrative Diagnosis of Sickle Cell Disease (SCD) and Other Rare Anemia Disorders (RADs) for Personalized Medicine
Status:
RECRUITING
Status Verified Date:
2025-09
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:
INTEGRA
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 generation methodologies.
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 SCD/RADs patients genetic and phenotypic characterization.
* To identify genetic modifiers of RADs both new and previously described by GWAS as markers for prognosis and clinical course based on genomics approach.
* To establish an innovative algorithm for RADs patients characterization based on the integration of data generated through the analysis of genetic modifiers and the RBCs rheological properties by LoRRca profiles and microfluidics data in combination with RADs patients' clinical manifestations and treatments.
* To model the progression of RADs in a spleen-like filtering unit using microfluidic technologies to develop a novel diagnostic device for prognosis and patients' stratification. This device will be used for the characterization under flow of rheological and mechanical properties of single RBCs.
* To translate the results on a clinical practice recommendation for management of RADs patients endorsed by European Hematology bodies as ERN-EuroBloodNet and/or the European Hematology Association for its wide dissemination.
* 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 SCD/RADs patients genetic and phenotypic characterization.
* To identify genetic modifiers of RADs both new and previously described by GWAS as markers for prognosis and clinical course based on genomics approach.
* To establish an innovative algorithm for RADs patients characterization based on the integration of data generated through the analysis of genetic modifiers and the RBCs rheological properties by LoRRca profiles and microfluidics data in combination with RADs patients' clinical manifestations and treatments.
* To model the progression of RADs in a spleen-like filtering unit using microfluidic technologies to develop a novel diagnostic device for prognosis and patients' stratification. This device will be used for the characterization under flow of rheological and mechanical properties of single RBCs.
* To translate the results on a clinical practice recommendation for management of RADs patients endorsed by European Hematology bodies as ERN-EuroBloodNet and/or the European Hematology Association for its wide dissemination.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Evidence 860436 | OTHER_GRANT | EC-H2020-MSCA-ITN-2019 | View | |
| Integra-SCD PI20/01454 | OTHER_GRANT | Instituto de Salud Carlos III (ISCIII) | View | |
| GA 101095530 - SYNTHEMA | OTHER_GRANT | HORIZON-HLTH-2022-IND-13-02 | View | |
| GA 101017549 - GENOMED4ALL | OTHER_GRANT | H2020-SC1-FA-DTS-2020-1 | View | |
| PR(AMI)427/2021 | OTHER_GRANT | RADeep (Rare Anaemia Disorders European Epidemiological Platform) | View |