The Association Between Gut Microbiome Composition Signature and Cancer-related Symptoms in Children With Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires set, fecal sample collecting.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Association Between Gut Microbiome Composition Signature and Cancer-related Symptoms in Children With Acute Lymphoblastic Leukemia: A Longitudinal Study
Overview
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.
Detailed description
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.
Interventions
- Other 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 - Other 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.
Primary outcome measures
- Cancer-related symptoms [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
\- (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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University; The First Affiliated Hospital of Su — Guangzhou
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07515430 · gut-longitudinal study