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Идёт набор NCT05504772

Precision Medicine for Every Child With Cancer

— Наблюдательное Childhood Cancer Childhood Solid Tumor Childhood Brain Tumor Childhood Leukemia

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: Whole Genome Sequencing, RNA seq, DNA Methylation, Targeted Panel Sequencing.
Кому может быть актуально
Состояния в реестре: Childhood Cancer, Childhood Solid Tumor, Childhood Brain Tumor, Childhood Leukemia. Базовые параметры: 0 лет — 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
Австралия, Новая Зеландия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

To improve outcomes for childhood cancer patients through the implementation of precision medicine.

Подробное описание

Through the pilot TARGET and national PRISM trials the feasibility and benefits of using comprehensive molecular profiling and preclinical drug testing in real time for high-risk (HR) patients has been demonstrated. However, the role of precision medicine, especially in facilitating diagnosis and risk stratification in non-HR childhood cancers has not been studied. Integrative tumor-germline whole genome sequencing (WGS) analysis has the potential to advance our understanding of cancer predisposition. In this study, the ZERO platform will be extended to all children with cancer in Australia and New Zealand, evaluating the benefits of precision medicine in different childhood cancer types and risk groups.

Вмешательства

  • Генная терапия Whole Genome Sequencing
    Each tumor sample will be sequenced and analyzed in parallel with its matched normal (germline DNA from the same patient) to enable the identification of somatic aberrations.
  • Генная терапия RNA seq
    Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
  • Генная терапия DNA Methylation
    Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
  • Генная терапия Targeted Panel Sequencing
    Targeted panel sequencing may be performed: 1. When WGS is not feasible or appropriate, e.g., insufficient DNA from fresh or frozen sample or only Formalin-Fixed Paraffin-Embedded (FFPE) material is available 2. When mosaicism is suspected 3. When indicated for a disease type
  • Генная терапия High Throughput Sequencing (in vitro)
    High throughput drug screening will be attempted for tumors from Cohort 1 (high-risk cancers with survival \<30%) and selected tumor types.
  • Генная терапия Patient Derived Xenograft (PDX)(in vivo)
    In vivo drug testing in patient derived xenograft (PDX) will be attempted for tumors from Cohort 1 (high-risk cancers) and selected tumor types.
  • Другое Liquid Biopsy
    Liquid biopsy will be investigated as a non-invasive method for diagnosis of tumors that are difficult to biopsy directly, understanding tumor heterogeneity, monitoring of treatment response, and detection of minimal residual disease (MRD)/relapse in leukemia, solid and CNS tumors.

Первичные конечные точки

  • Utility of recommended personalized therapy for HR childhood cancer patients. [Срок оценки: 5 years]
  • Utility of recommended personalized therapy for non-HR childhood cancer patients. [Срок оценки: 5 years]
Вторичные конечные точки (6)
  • Utility of pre-defined virtual molecular panel for non-HR childhood cancer patients. [Срок оценки: 5 years]
  • Utility of comprehensive precision medicine for patients with rare tumors in childhood. [Срок оценки: 5 years]
  • Utility of Molecular Tumour Board (MTB) recommendation tier system for HR childhood cancer patients. [Срок оценки: 5 years]
  • Utility of preclinical testing in HR childhood cancer patients. [Срок оценки: 5 years]
  • Clinical utility of germline WGS in patients with childhood cancers. [Срок оценки: 5 years]
  • Treatment outcome in HR childhood cancer patients who have received recommended personalised therapy which are molecularly and/or preclinically directed. [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Age < 18 years Note: Individual patients aged 19 - 25 years old with a pediatric cancer, e.g., neuroblastoma, may be enrolled after discussion with, and at the discretion of, the Study Chair or their delegate.
  • Life expectancy >6 weeks at time of enrolment
  • Consent i. Signed and dated informed consent for study enrolment from participant aged ≥ 18 years or from parent/guardian of participant aged <18 years. ii. Separate signed and dated informed consent for understanding the role of germline testing and choice for the return of germline results.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Австралия · 9 центров
  • Women's and Children's Hospital — Adelaide
  • Queensland Children's Hospital — Brisbane
  • Royal Hobart Hospital — Hobart
  • Monash Children's Hospital — Melbourne
  • Royal Children's Hospital — Melbourne
  • John Hunter Children's Hospital — Newcastle
  • Perth Children's Hospital — Perth
  • Sydney Children's Hospital, Randwick — Sydney
  • … и ещё 1 центр
Новая Зеландия · 2 центра
  • Starship Children's Hospital — Auckland
  • Christchurch Hospital — Christchurch

Идентификаторы

NCT: NCT05504772 · ZERO2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗