RecruitingNCT07450872

Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors

A Multicenter Study on the Heterogeneity of Symptom Clusters and the Underlying Mechanisms of Gut Microbiota and Metabolites Among Childhood Cancer Survivors

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Enrollment

600 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Cancer Glioma Leukemia (Both ALL and AML)

Summary

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.

Eligibility

Min Age: 8 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating patterns of symptoms — such as fatigue, pain, emotional distress, and sleep problems — in childhood cancer survivors and exploring whether differences in gut bacteria (the microbiome) may explain why some survivors experience more severe symptoms than others. Both children and their primary caregivers are being enrolled. **You may be eligible if (Children):** - You are between 8 and 18 years old - You have a confirmed cancer diagnosis (leukemia, lymphoma, brain tumor, or other common solid tumors) - You are currently in the maintenance or rehabilitation phase of treatment, OR you finished treatment at least 6 months ago - You are able to independently understand and complete questionnaires **You may be eligible if (Caregivers):** - You are the primary caregiver of an eligible child - You are 20 years of age or older - You can understand the study and complete the required questionnaires **You may NOT be eligible if:** - The child has severe treatment-related organ damage or neurological problems that make symptom assessment unreliable - The caregiver has experienced a major life event (bereavement, divorce) in the past 6 months - Either participant has severe cognitive impairment or psychiatric disorders preventing participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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