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

Sponsor
Sun Yat-sen University
Study ID
NCT07515430
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Questionnaires set — OTHER
    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 weekly from the start of chemotherapy until the end of induction chemotherapy or Re-induction I.
  • fecal sample collecting — OTHER
    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.

Study Details

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.

Key Dates

First listed
Apr 7, 2026
Start date
Feb 1, 2026
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
138 participants (estimated)

Arms

  • Arm: Questionnaires assessed children with acute lymphoblastic leukemia
    1. 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. 2. 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)\*. 3. Conscious and capable of answering questions. 4. Voluntarily agree to participate in the study. 5. Planned to undergo a full cycle of induction chemotherapy.

Primary Outcome Measure

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 ]

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