Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors (NCT07450872) | Clinical Trial Compass
RecruitingNot Applicable
Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors
China600 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ap…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symptom Cluster Severity and Structure in Childhood Cancer Survivors
Timeframe: Baseline, 3 months, and 6 months after enrollment
Trial details
NCT IDNCT07450872
SponsorThe Children's Hospital of Zhejiang University School of Medicine