RecruitingNot Applicable

Integrative Diagnosis for SCD and Other RADs

Spain200 participantsStarted 2020-11-13

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Carrier traits in autosomal recessive hereditary anemias

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the prognostic value of LoRRca ektacytometry as biomarker providing information of SCD/RADs patients severity

Timeframe: Through study completion, an average of 2 year

Trial details

NCT IDNCT07206095

SponsorHospital Universitari Vall d'Hebron Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-25

Contact for this trial

Mar Mañú Pereira PhD

+34 93 489 4063 mar.manu@vhir.org

View on ClinicalTrials.gov More Sickle Cell Disease trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.