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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• Aged 8-18 years; Clinically and pathologically confirmed diagnosis of cancer (including leukemia, lymphoma, central nervous system tumors, or other common solid tumors); Currently in the rehabilitation/maintenance phase or completed treatment ≥6 months prior to enrollment; No cognitive impairment; able to understand, communicate, and complete questionnaires independently; Written informed consent/assent obtained from participants and their legal guardians.

• Primary caregiver of an eligible CCS participant; Aged ≥20 years; Able to understand study content and complete questionnaires, with adequate literacy and communication ability; Written informed consent provided prior to participation.

Locations
Other Locations
China
Children's Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Jinhu Wang, Doctor of Medicine
tangyinbing@zju.edu.cn
86+13606636547
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 600
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: The Children's Hospital of Zhejiang University School of Medicine
Collaborators: Jiangxi Province Children's Hospital, Fujian Maternity and Child Health Hospital

This content was sourced from clinicaltrials.gov