Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Study ID
NCT07450872
Status
Recruiting
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Conditions

  • Cancer
  • Glioma
  • Leukemia (Both ALL and AML)

Eligibility Criteria

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

Study Details

Advances in medical care have significantly improved survival among children with cancer. In China, the 5-year survival rate has reached 71.9%. Despite these improvements, many survivors continue to experience multiple co-occurring symptoms, such as fatigue, pain, sleep disturbance, and depression, which may adversely affect their quality of life. These symptoms often occur together as symptom clusters and may reflect shared underlying biological mechanisms. This study aims to characterize symptom clusters among childhood cancer survivors and to explore their potential biological basis. Participants will complete questionnaire assessments at multiple time points to evaluate symptom patterns and changes over time. In addition, stool samples will be collected to analyze gut microbiota composition and metabolite profiles. The study will examine the associations between symptom clusters and gut microbiota-metabolite features. Findings from this study are expected to improve understanding of symptom burden in childhood cancer survivors and to provide evidence for the development of targeted symptom management strategies.

Key Dates

First listed
Mar 5, 2026
Start date
Jan 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Childhood Cancer Survivors and Their Primary Caregivers
    This cohort includes children aged 8-18 years diagnosed with cancer (leukemia, lymphoma, CNS tumors, or common solid tumors) who have completed active treatment or are in maintenance/recovery for ≥6 months. Eligible children must have normal cognitive and communication abilities. Primary caregivers are adults aged ≥ 20 years who provide main care and can complete assessments. Exclusion criteria include severe treatment-related complications, cognitive or communication impairments, inability to complete study procedures independently, recent major life events for caregivers, or concurrent interventions affecting outcomes. No interventions are applied; this is an observational study. Data collection includes repeated symptom assessments and stool sample analysis to explore gut microbiota and metabolite associations with symptom clusters.

Primary Outcome Measure

Symptom Cluster Severity and Structure in Childhood Cancer Survivors [ Time Frame: Baseline, 3 months, and 6 months after enrollment ]

Central Contacts

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