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Набор скоро начнётся NCT07483476

Study of Cell-free DNA in Children and Adolescents With Acute Lymphoblastic Leukemia

— Наблюдательное Acute Lymphoblastic Leukemia ALL

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: Biological sample collection.
Кому может быть актуально
Состояния в реестре: Acute Lymphoblastic Leukemia ALL. Базовые параметры: до 18 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
Список центров уточняется — проверьте первичный протокол.
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

Etude de l'ADN Libre Circulant Dans Les leucémies Aigues Lymphoblastiques de l'Enfant et de l'Adolescent

Обзор

Minimal residual disease (MRD) monitoring is a key prognostic factor in pediatric acute lymphoblastic leukemia (ALL). Currently, MRD assessment relies mainly on cellular DNA obtained from bone marrow aspirates. Although highly informative, this approach has limitations, including the need for invasive procedures and the fact that it reflects only the bone marrow compartment. Tumor cells release fragments of genomic DNA into the bloodstream, known as circulating cell-free DNA (cfDNA). In solid tumors, cfDNA analysis has emerged as a valuable non-invasive biomarker for disease monitoring and treatment response. Recent studies have shown that cfDNA is detectable in pediatric ALL. This study aims to investigate whether plasma cfDNA analysis could represent an alternative or complementary approach to bone marrow-based MRD assessment. cfDNA may better reflect the global tumor burden across the entire body and allow more frequent longitudinal monitoring during treatment. The primary objective is to assess the correlation between MRD measured in plasma cfDNA and MRD measured in bone marrow cellular DNA at two key timepoints of treatment: the end of induction (Day 29) and the end of consolidation (Day 71-78). Secondary objectives include evaluating the correlation between peripheral blood cellular DNA and bone marrow MRD, describing clonal evolution using cfDNA throughout treatment and follow-up, exploring the concordance of genomic alterations detected in cfDNA and other biological compartments, assessing the prognostic value of cfDNA MRD for relapse risk and event-free survival, and characterizing cfDNA fragmentome and methylome signatures in patients compared with healthy controls. The study will include children and adolescents with newly diagnosed ALL treated at two AP-HP pediatric hematology centers, as well as a control cohort of healthy children undergoing HLA typing for sibling stem cell transplant.

Вмешательства

  • Другое Biological sample collection
    Additional peripheral blood samples will be collected during treatment and follow-up for cell-free DNA analysis. Residual samples from bone marrow and cerebrospinal fluid collected as part of standard clinical care will also be analyzed.

Первичные конечные точки

  • Correlation between plasma cfDNA MRD and bone marrow MRD [Срок оценки: Up to day 78 (end of consolidation)]
Вторичные конечные точки (12)
  • Correlation between peripheral blood cellular DNA MRD and bone marrow MRD [Срок оценки: At day 29]
  • Correlation between peripheral blood cellular DNA MRD and bone marrow MRD [Срок оценки: At day 78]
  • Clonal evolution detected in cell-free DNA [Срок оценки: At day 1]
  • Clonal evolution detected in cell-free DNA [Срок оценки: At day 4]
  • Clonal evolution detected in cell-free DNA [Срок оценки: At day 8]
  • Clonal evolution detected in cell-free DNA [Срок оценки: At day 15]
  • Clonal evolution detected in cell-free DNA [Срок оценки: At day 29]
  • Clonal evolution detected in cell-free DNA [Срок оценки: At day 78]
  • Clonal evolution detected in cell-free DNA [Срок оценки: At end of maintenance]
  • Clonal evolution detected in cell-free DNA [Срок оценки: 3 years after remission]
  • Concordance of genomic alterations between cfDNA and other biological compartments [Срок оценки: At diagnosis]
  • Prognostic value of cfDNA MRD [Срок оценки: Up to 5 years of follow-up]

Критерии участия

Критерии включения

ALL population

  • Age < 18 years
  • Newly diagnosed B-cell or T-cell acute lymphoblastic leukemia
  • Absence of BCR::ABL1 rearrangement
  • For infants (<12 months), absence of KMT2A rearrangement
  • Inclusion before initiation of corticosteroid therapy or chemotherapy
  • Written informed consent from legal guardians
  • Affiliation to a national health insurance system Control population
  • Age < 18 years
  • Undergoing blood sampling for HLA typing in the context of bone marrow donor evaluation
  • Sibling of a patient with leukemia
  • Written informed consent from legal guardians
  • Affiliation to a national health insurance system

Критерии исключения

  • Pregnant or breastfeeding patients
  • Patients not affiliated with a health insurance system

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07483476 · 2025-A01461-48

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗