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Congenital Hemolytic and Dyserythropoietic Anemias

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.

研究概览

地位

招聘中

详细说明

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.

研究类型

观察性的

注册 (估计的)

400

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Ohio
      • Cincinnati、Ohio、美国、45229
        • 招聘中
        • Cincinnati Children's Hospital Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants with an Established Molecular Diagnosis of a Red Blood Cell Disorder
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Number of Participants with Identified Novel Genetic Variants Associated with Red Blood Cell Disorders
大体时间: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
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2011年7月25日

初级完成 (估计的)

2050年7月1日

研究完成 (估计的)

2052年7月1日

研究注册日期

首次提交

2026年2月11日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • Congenital Hem/2011-1510

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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