The Association Between Gut Microbiome Composition Signature and Cancer-related Symptoms in Children With Acute Lymphoblastic Leukemia

Официальное название

The Association Between Gut Microbiome Composition Signature and Cancer-related Symptoms in Children With Acute Lymphoblastic Leukemia: A Longitudinal Study

Обзор

This study is a prospective longitudinal investigation. Data on disease-related information, gut microbiota composition, cancer-related symptoms, dietary intake, and levels of pro-inflammatory cytokines, LPS were collected repeatedly at the following time points: before chemotherapy initiation, at the end of induction chemotherapy or Re-induction I, at 8 weeks after induction or re-induction therapy, at three months after induction or re-induction therapy, as well as weekly between chemotherapy initiation and the end of induction chemotherapy or Re-induction I. The aim is to explore the relationship between gut microbiota composition and cancer-related symptoms.

Подробное описание

This study is a prospective longitudinal investigation. (1) Describe the composition characteristics and dynamic changes of the gut microbiota in children with ALL, assessed weekly from before chemotherapy initiation until the end of induction chemotherapy or Re-induction I, as well as at 8 weeks and three months after the completion of induction or re-induction therapy.

(2) Describe the severity levels and dynamic changes of cancer-related symptoms in children with ALL, assessed weekly from before chemotherapy initiation until the end of induction chemotherapy or Re-induction I, as well as at 8 weeks and three months after the completion of induction or re-induction therapy.

(3) Investigate the correlations between gut microbiota composition, lipopolysaccharide (LPS), inflammatory cytokines (IL-6, IL-1β, TNF-α), and serotonin (5-HT) with cancer-related symptoms in children with ALL, assessed at the time points specified in (1) and (2).

(4) Explore the main factors influencing the characteristics of gut microbiota composition in children with ALL from baseline to three months after the completion of induction or re-induction therapy.

Вмешательства

• Другое Questionnaires set
  Planned to undergo a complete cycle of induction chemotherapy, with repeated collection of data including disease-related information, cancer-related symptoms, dietary records, and pro-inflammatory cytokine questionnaires. These data will be collected at the following time points: before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as
• Другое fecal sample collecting
  Planned to undergo a complete cycle of induction chemotherapy, with repeated collection of fecal sample. These data will be collected at the following time points: before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherapy until the end of induction chemotherapy or Re-induction I.

Первичные конечные точки

• Cancer-related symptoms [Срок оценки: before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherap]
• Cancer-related symptoms [Срок оценки: before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherap]
• Cancer-related symptoms [Срок оценки: before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherap]
• Gut microbiota signature [Срок оценки: before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherap]

Критерии участия

Критерии включения

• Aged between 5 and 18 years; considering that children over 5 are able to cooperate with the survey, the age range for this study is limited to 5-18 years.
• Confirmed diagnosis of ALL according to the MICM (morphology, immunology, cytogenetics, and molecular) criteria, following the \*South China Children's Acute Lymphoblastic Leukemia Treatment Collaborative Group 2023 Protocol (SCCCG-ALL-2023)\*.
• Conscious and capable of answering questions.
• Voluntarily agree to participate in the study.
• Planned to undergo a full cycle of induction chemotherapy.

Критерии исключения

\- (1) Presence of gastrointestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.) or recent gastrointestinal surgery.

(2) Previous treatment with probiotics or fecal microbiota transplantation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University; The First Affiliated Hospital of Su — Гуанчжоу
• The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT07515430 · gut-longitudinal study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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