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Congenital Hemolytic and Dyserythropoietic Anemias

15 de junho de 2026 atualizado por: Children's Hospital Medical Center, Cincinnati

The main reason for this research study is to further understand how some red blood cells are formed incorrectly or they have an abnormal metabolism in a way that they break easier in the circulation or during their passage through the spleen.

Participants and/or family members diagnosed with non-immune hemolytic anemia due to a genetic disorder, such as, hemoglobin disorder, erythrocyte membrane skeleton disorders (e.g. spherocytosis, elliptocytosis, or stomatocytosis) or hydration defect (e.g. xerocytosis, overhydrocytosis) or red blood cell (RBC) enzyme disorders, or with a congenital dyserythropoietic anemia (CDA) will be asked to participate.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

The purpose of this study is to explore for known or yet unknown genetic mutations causative for non-immune hemolysis and/or anemia, in patients with hemoglobin disorders, membrane skeleton defects (a group of diseases including hereditary spherocytosis, hereditary elliptocytosis and pyropoikilocytosis, and hereditary stomatocytosis syndromes), RBC enzymopathies (most common of them being glucose-6-phosphate dehydrogenase (G6PD) and pyruvate kinase deficiency), and congenital dyserythropoietic anemias. The goal is to optimize genetic diagnosis for patients with non-immune congenital hemolytic anemias, and advance research on the pathogenesis and potentially improve treatment options for these rare disorders. The investigators include analysis for genes that are known or suspected to participate in the making of healthy red blood cells. Sequencing analysis of the UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) is also included because the clinical care of these patients frequently necessitate such testing to evaluate for increased risk of cholelithiasis, due to co-inheritance of Gilbert syndrome.

This is a non-interventional study, focusing on improving diagnosis and understanding the mechanisms of how abnormalities of genes may affect the making and survival of red blood cells.

The traditional tests that usually suggest the diagnosis of an erythrocyte cytoskeleton defect or a RBC enzymopathy (erythrocyte morphology in the blood smear, osmotic fragility test, and ektacytometry or enzyme activity assay respectively) do not always provide a definitive diagnosis, especially because the diagnosis with those methods requires a pure population of the patient's red blood cells, obtainable three months after last PRBC transfusion, and is therefore complicated or impossible in the patients who need frequent transfusions. Erythrocyte membrane proteins can be prepared from washed red blood cells or potentially from isolated reticulocytes from the patient. Analysis of such sample by electrophoresis on polyacrylamide gel followed by western blot for specific proteins can be a valuable tool that orients towards the diagnosis and may point to the specific gene responsible for the disease.

The investigators propose a systematic approach to improve diagnostic evaluation of such diseases by completing a parallel analysis of ektacytometry, erythrocyte membrane proteins electrophoresis and western blot along with full exon sequencing using genomic DNA from isolated white blood cells in blood samples donated from approximately 400 patients and their parents. Our goal is to identify specific mutation(s) responsible for the patients' congenital hemolytic or dyserythropoietic anemia, and develop a genetic approach to the diagnosis of such diseases. In addition, such genetic data will offer valuable information towards understanding the pathogenesis of this group of diseases.

Tipo de estudo

Observacional

Inscrição (Estimado)

400

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45229
        • Recrutamento
        • Cincinnati Children's Hospital Medical Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

If medical history and review of the laboratory data obtained for clinical care, including CBC/reticulocyte count and review of the blood smear, indicates that the patient has a non-immune hemolytic anemia that may be due to a hemoglobinopathy, a red cell membrane skeleton or enzyme disorder, then the patients and their families will be asked for their participation in the study. The rare patients suspected to have congenital dyserythropoietic anemia will also be eligible for this study.

Descrição

Inclusion Criteria:

  1. Patients who have been diagnosed, by medical history and review of the laboratory data obtained for clinical care, including CBC/reticulocyte count and review of the blood smear, with a hereditary hemolytic anemia, where the genetic etiology is challenging to be identified.
  2. Parents and/or grandparents of children that have the above diagnosis. The parents and/or grandparents may or may not have non-immune hemolytic anemia (these will serve as positive or negative inherent controls)

Exclusion:

1) Patients with anemias known to be acquired and not associated with a genetic etiology.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants with an Established Molecular Diagnosis of a Red Blood Cell Disorder
Prazo: From enrollment to completion of molecular and diagnostic evaluation (approximately 12-24 months)
The proportion of participants in whom a molecular diagnosis is established through genetic and laboratory evaluation, defined as identification of pathogenic or likely pathogenic variants associated with hereditary hemolytic anemia (including hemoglobin disorders, erythrocyte membrane disorders, and red blood cell enzymopathies) or dyserythropoietic anemia.
From enrollment to completion of molecular and diagnostic evaluation (approximately 12-24 months)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants with Identified Novel Genetic Variants Associated with Red Blood Cell Disorders
Prazo: From enrollment to completion of molecular and diagnostic evaluation (approximately 12-24 months)
The number of participants in whom previously unreported or novel genetic variants or novel candidate genes potentially associated with red blood cell disorders are identified through molecular testing.
From enrollment to completion of molecular and diagnostic evaluation (approximately 12-24 months)
Description of Genotype-Phenotype Associations in Participants with Red Blood Cell Disorders
Prazo: From enrollment to completion of molecular and diagnostic evaluation (approximately 12-24 months)
Assessment of the relationship between identified genetic variants and clinical and laboratory features, including effects on red blood cell production, morphology, and survival. Results will be summarized descriptively.
From enrollment to completion of molecular and diagnostic evaluation (approximately 12-24 months)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

25 de julho de 2011

Conclusão Primária (Estimado)

1 de julho de 2050

Conclusão do estudo (Estimado)

1 de julho de 2052

Datas de inscrição no estudo

Enviado pela primeira vez

11 de fevereiro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de junho de 2026

Primeira postagem (Real)

16 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Congenital Hem/2011-1510

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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