Symptom patterns and gut bacteria 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
This project will test whether groups of ongoing symptoms in childhood cancer survivors are linked to differences in gut bacteria and their metabolites.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07450872 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls childhood cancer survivors aged 8–18 who are in rehabilitation/maintenance or finished treatment at least six months earlier. Participants complete questionnaires at multiple time points to track symptom patterns such as fatigue, pain, sleep disturbance, and mood, and provide stool samples for gut microbiota and metabolite profiling. Researchers will perform longitudinal symptom-cluster analysis alongside microbiome and metabolome sequencing to identify associations between symptom clusters and microbial/metabolic features. The goal is to clarify biological mechanisms behind persistent symptom groups and identify microbial signals that could inform future supportive care strategies.
Who should consider this trial
Good fit: Ideal participants are childhood cancer survivors aged 8–18 who can complete questionnaires independently, are in rehabilitation/maintenance or at least six months post-treatment, and consent to provide stool samples.
Not a fit: Children with severe treatment-related organ or neurological impairments, those unable to complete questionnaires independently, or those starting new major cancer therapy during the study are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this work could point to microbiome-based or tailored supportive strategies to reduce symptom burden and improve quality of life for childhood cancer survivors.
How similar studies have performed: Prior human and animal studies have linked gut microbiota to fatigue, mood, and gastrointestinal symptoms, but applying microbiome and metabolite profiling specifically to symptom clusters in childhood cancer survivors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Children: 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. Exclusion Criteria for Children: Presence of severe treatment-related sequelae (e.g., significant organ dysfunction or neurological impairment) that may interfere with symptom assessment; Poor compliance or inability to independently complete interviews/questionnaires; Concurrent participation in other interventional clinical trials that may influence study outcomes; Planned major surgery or initiation of new chemotherapy/radiotherapy during the study period. Inclusion Criteria for Caregivers: 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. Exclusion Criteria for Caregivers: Experience of major adverse life events within the past 6 months (e.g., bereavement, divorce) that may affect psychological assessment Presence of severe cognitive impairment; Presence of severe aphasia, psychiatric disorders, or other conditions preventing independent completion of assessments.
Where this trial is running
Hangzhou, Zhejiang
- Children's Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Jinhu Wang, Doctor of Medicine
- Email: tangyinbing@zju.edu.cn
- Phone: 86+13606636547
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.