Symptom patterns and gut bacteria in childhood cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.