An observational study in Cancer, Glioma and Leukemia (Both ALL and AML), sponsored by The Children's Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Observational
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.
Background
Advances in diagnostic and therapeutic strategies have markedly improved survival among children with cancer. In high-income regions, the 5-year net survival rate for common childhood cancers has reached 80% to 95%, while in China the overall 5-year relative survival rate is approximately 71.9%. As survival improves, the number of childhood cancer survivors (CCS) continues to increase. However, the long-term impact of cancer and its treatment remains substantial.
Cancer treatments, including chemotherapy, radiotherapy, surgery, and targeted immunotherapy, may lead to a wide range of persistent physical and psychological symptoms. CCS often experience multiple concurrent symptoms, such as fatigue, pain, sleep disturbance, depression, and nausea. These symptoms frequently co-occur and interact, forming symptom clusters that may exacerbate overall symptom burden and negatively affect treatment outcomes, health-related quality of life, and long-term prognosis.
Symptom clusters have been widely reported across different cancer types and treatment stages. Despite observed heterogeneity, core symptom clusters-particularly physical, gastrointestinal, and psychological clusters-demonstrate relative stability across studies and over time. Longitudinal evidence suggests that while the number and composition of symptom clusters may vary, core clusters persist across treatment phases, indicating potential underlying biological mechanisms.
In addition to psychosocial factors, emerging evidence highlights the role of the gut microbiota and its metabolites in influencing host physiology and symptom expression. The gut microbiota interacts with the host through metabolic, immune, and neuroendocrine pathways, and may contribute to symptom heterogeneity via interconnected systems such as the gut-brain axis. Chemotherapy-induced inflammation and intestinal barrier disruption may further mediate these processes, suggesting a potential biological basis for persistent symptom clusters in CCS.
Rationale
Although symptom clusters in CCS have been increasingly studied, several critical gaps remain. First, most existing studies rely on cross-sectional data or short-term follow-up, limiting the ability to assess the long-term stability of symptom clusters. Second, research is often restricted to single cancer types or treatment stages, lacking comprehensive evaluation across diseases and treatment trajectories. Third, the identification of core symptoms and clusters is often inconsistent, with limited use of quantitative indicators to assess stability across time.
Furthermore, while psychosocial factors have been explored, the biological mechanisms underlying symptom clusters remain insufficiently understood. In particular, prospective evidence linking gut microbiota, metabolites, and symptom clusters in pediatric cancer populations is scarce. Existing studies are often limited to animal models or single biological pathways, and do not capture the complex interactions within the microbiota-immune-neuro network.
Addressing these gaps is essential for improving the understanding of symptom cluster heterogeneity and stability, and for identifying potential targets for intervention. A comprehensive approach integrating longitudinal symptom assessment with microbiome and metabolomic data may provide novel insights into the mechanisms underlying symptom clusters in CCS.
Objectives
The primary objective of this study is to characterize the heterogeneity and stability of symptom clusters among childhood cancer survivors and to explore their underlying mechanisms.
The specific objectives are:
This study aims to provide evidence for a more comprehensive understanding of symptom burden in CCS and to inform the development of targeted, mechanism-based symptom management strategies.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 600 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 69 studies on the registry; 52 are open to participants now.
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This study will recruit childhood cancer survivors (CCS) aged 8-18 years and their primary caregivers. Eligible CCS have a clinically confirmed diagnosis of cancer (including leukemia, lymphoma, central nervous system tumors, and other common solid tumors) and are in the rehabilitation/maintenance phase or have completed treatment ≥6 months prior to enrollment. Participants must have no cognitive impairment and be able to understand, communicate, and complete assessments.
Primary caregivers aged ≥20 years who provide daily care for eligible CCS will also be included. All participants will provide informed consent/assent.
This cohort captures diverse cancer types and survivorship stages to examine symptom clusters, their longitudinal trajectories, and related psychosocial and biological factors, including gut microbiota and metabolites.
Inclusion Criteria for Children:
Exclusion Criteria for Children:
Inclusion Criteria for Caregivers:
Exclusion Criteria for Caregivers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Symptom Cluster Severity and Structure in Childhood Cancer Survivors
Symptom clusters will be assessed using validated patient-reported outcome instruments measuring fatigue, pain, sleep disturbance, depression, and related symptoms. Latent growth mixture modeling and network analysis will be used to identify cluster structures, severity levels, and longitudinal trajectories. Higher scores indicate greater symptom burden and more severe clustering patterns.
Time frame: Baseline, 3 months, and 6 months after enrollment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — We have not yet determined whether individual participant data (IPD) will be shared because the dataset includes sensitive information from children and their parents, as well as biological data (e.g., microbiome data), which raises privacy and ethical considerations. Decisions regarding data sharing will depend on institutional policies, ethical approvals, and the development of appropriate data protection and de-identification procedures.
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The Children's Hospital of Zhejiang University School of Medicine