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Идёт набор NCT05929976

InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

— Наблюдательное Acute Lymphoblastic Leukemia Nutrition Aspect of Cancer Microtia Genetic Predisposition

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: No intervention.
Кому может быть актуально
Состояния в реестре: Acute Lymphoblastic Leukemia, Nutrition Aspect of Cancer, Microtia, Genetic Predisposition. Базовые параметры: 3 лет — 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
США, Бразилия, Guatemala, Honduras, Индия +1
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

Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Обзор

Nutritional status is a measurable and modifiable factor that is often not considered during treatment and its clinical impact undervalued due in part to the heavy demands on clinicians in low and middle income countries to deliver therapy to large numbers of patients. The proposed study will create a biobank of clinical data and biological specimens which will foster future studies on cancer progression and prognosis as well as toxicities during treatment which may impact survivorship and late-effects. Eligible patients must be between 3 years and 18 years of age at time of assent/consent, have newly diagnosed B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia confirmed by pathology report, and must be receiving treatment at one of the participating centers. Patients receiving hematopoietic cell transplant will be excluded. Institutions were selected to ensure representation of several global health indicators related to nutritional status and wealth classification according to the World Bank. Data related to demographic variables (socioeconomic status, food security), lifestyle habits (diet, physical activity), nutritional anthropometrics (height, weight and arm anthropometry), and nutritional biological indices (stool and blood) will be collected at designated timepoints throughout treatment and one year after the end of treatment.

Вмешательства

  • Другое No intervention
    No intervention

Первичные конечные точки

  • Create a prospective multinational biorepository of pediatric specimens (stool, blood) obtained at diagnosis, end of induction, beginning of maintenance, end of treatment, and 1-year after treatment among children/adolescents with ALL. [Срок оценки: 7 years]
  • Collect sociodemographic data at sequential timepoints during treatment for ALL. [Срок оценки: 7 years]
  • Collect dietary data at sequential timepoints during treatment for ALL. [Срок оценки: 7 years]
  • Collect physical activity data at sequential timepoints during treatment for ALL. [Срок оценки: 7 years]
  • Collect clinical information (disease characteristics, treatment-related toxicities, survival) at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens. [Срок оценки: 7 years]
  • Collect nutritional anthropometrics at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens. [Срок оценки: 7 years]

Критерии участия

Критерии включения

  • Patients must be between 3 years and 18 years of age at time of assent/consent.
  • Patients must have newly diagnosed B- or T-cell ALL, or mixed phenotype acute leukemia confirmed by pathology report.
  • Patients must be receiving treatment at one of the participating centers.

Критерии исключения

\- Patients receiving hematopoietic cell transplant.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бразилия · 3 центра
  • Hospital de Cancer Infanto Juvenil de Barretos — Barretos
  • Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) — Recife
  • Instituto de Tratamento do Câncer Infantil (ITACI) — São Paulo
США · 1 центр
  • Columbia University Irving Medical Center — New York
Guatemala · 1 центр
  • Unidad Nacional De Oncologia Pediatrica — Guatemala City
Honduras · 1 центр
  • Hospital Escuela — Tegucigalpa
Индия · 1 центр
  • Post-Graduate Institute of Medical Education and Research (PGIMER) — Chandigarh
Tanzania · 1 центр
  • Muhumbili Hospital — Dar es Salaam

Идентификаторы

NCT: NCT05929976 · AAAU1407

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗