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RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: Analysis of genetic modifiers for Sickle Cell Disease

INTEGRA aims at enabling personalized medicine for RADs patients by the establishment of an integrative diagnostic approach based on deep phenotypic and genetic characterization through combining new generation methodologies.

Official registry: https://clinicaltrials.gov/study/NCT07206095 · Hospital Universitari Vall d'Hebron Research Institute · enrollment listed as 350

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 350 people at 4 sites. Taking part typically means genetic testing or a gene-targeted therapy plus check-ins.

Official title (unrewritten)

Integrative Diagnosis of Sickle Cell Disease (SCD) and Other Rare Anemia Disorders (RADs) for Personalized Medicine

Interventions: Analysis of genetic modifiers, Disease phenotyping

Primary outcome (registry wording): To assess the prognostic value of LoRRca ektacytometry as biomarker providing information of SCD/RADs patients severity

Who it is for (from inclusion criteria)

  • Patients sustaining a confirmed or suspected diagnosis of an hereditary rare hemolytic anemia:
  • Sickle cell disease (SCD) Thalassaemia syndromes Congenital dyserythropoietic anaemia (CDA) Enzymopathies Unstable haemoglobin / altered oxygen affinity Hereditary stomatocytosis Hereditary pyropoikilocytosis
  • Hereditary spherocytosis (HS), either severe (baseline Hb \<10 g/dL or transfusion-dependent) or with an inconclusive diagnosis:
  • Patient with chronic haemolytic anaemia and a compatible red cell smear, but with:
  • EMA binding test: inconclusive or negative Genetic testing: no definitive diagnosis (VUS or no findings)

Public study contact (from the registry)

Mar Mañú Pereira PhD

+34 93 489 4063

mar.manu@vhir.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseWashington D.C., District of Columbia
Natural History of Sickle Cell Disease

This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated.

NCT00081523 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)

RecruitingNot a traditional drug phaseBethesda, Maryland
Blood Sampling for Research Related to Sickle Cell Disease

This study will collect representative blood samples from healthy children and adults and from children and adults who have unique red blood cell features that are related to sickle cell disease. Sickle cell disease is a blood disease that limits the ability of red blood cells to carry oxygen throughout the body.

NCT00542230 · Official ClinicalTrials.gov record · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

FAQ about this NCT record

Is NCT07206095 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07206095?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07206095?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary