Идёт набор NCT05772559

Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies

— Наблюдательное Acute Myeloid Leukemia Genetic Predisposition to Disease

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: В протоколе указаны: Collection of blood sample of bone marrow (cohort 1), Collection of blood sample of bone marrow (cohort 2 and 3).
Кому может быть актуально: Состояния в реестре: Acute Myeloid Leukemia, Genetic Predisposition to Disease. Базовые параметры: до 25 лет · 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: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies - ALARM3

Обзор

Pediatric acute myeloid leukemias are disease with poor prognosis (overall survival of 60-75%) and high relapse rate of 35-45% require further understanding of the underlying biological mechanisms. The main objective of this study is to establish a biological collection to evaluate the genomic profiling of leukemic cells from primary blasts at diagnosis and/or relapse to improve identification of the main genetic hits involved in resistance and could predict a high risk of relapse. Other objectives include the study of bone marrow mesenchymal stem cells and ex vivo drug testing.

Вмешательства

Другое Collection of blood sample of bone marrow (cohort 1)
* 3 additional tubes of blood sample (cohort 1), at diagnosis and upon relapse if relapse occurs * Bone marrow aspirate : 3 additional tubes (cohort 1), at diagnosis and upon relapse if relapse occurs
Другое Collection of blood sample of bone marrow (cohort 2 and 3)
* 1 additional tube of blood sample (cohort 2 and 3 at inclusion) * Bone marrow aspirate: 1 additional tube (cohort 2 and 3 at inclusion)

Первичные конечные точки

Number of somatic mutations in leukemic cells between diagnosis and relapse identified by Next-Generation Sequencing (NGS) [Срок оценки: Up to 5 years]

Вторичные конечные точки (12)

Cumulative incidence of relapse (CIR) from remission status. [Срок оценки: Up to 5 years]
Event Free Survival (EFS) [Срок оценки: Up to 5 years]
Disease Free Survival (DFS) [Срок оценки: Up to 5 years]
Number of mutations identified by WGS [Срок оценки: Up to 5 years]
Expression profile (transcriptome) of mesenchymal stem cells [Срок оценки: Up to 5 years]
Engraftment rate of primary leukemic cells [Срок оценки: Up to 5 years]
Matched rate of genetic mutational (or expression) profile between derived cells from experimental models to primary leukemic cells [Срок оценки: Up to 5 years]
Comparison of LSC signature profile of leukemic primary blasts at diagnosis and at relapse [Срок оценки: Up to 5 years]
Cumulative incidence of relapse according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse [Срок оценки: Up to 5 years]
EFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse [Срок оценки: Up to 5 years]
DFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse [Срок оценки: Up to 5 years]
Ex vivo multidrug testing profile of leukemic primary blasts [Срок оценки: Up ot 5 years]

Критерии участия

Критерии включения

0-25 years old
Newly diagnosed de novo or secondary Acute Myeloid Leukemia (AML) or
Relapsed or refractory AML or
Patients with genetic predisposition to develop AML or
Patients without haematological malignancy nor AML genetic predisposition syndrome who undergo bone marrow aspirate as part of standard of care
Signed informed consent of parents for patients aged less than 18 years old or signed informed consent of the patient for patients aged 18 and over.