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Идёт набор NCT07649213

Congenital Hemolytic and Dyserythropoietic Anemias

Наблюдательное Hemolytic Anemia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Hemolytic Anemia. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Percentage of Participants with an Established Molecular Diagnosis of a Red Blood Cell Disorder [Срок оценки: From enrollment to completion of molecular and diagnostic evaluation (approximately 12-24 months)]

Критерии участия

Критерии включения

  • 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.
  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • Cincinnati Children's Hospital Medical Center — Cincinnati

Идентификаторы

NCT: NCT07649213 · Congenital Hem/2011-1510

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗