NCT07450872 Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors
| NCT ID | NCT07450872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2026-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Jinhu Wang
STUDY CHAIR
The Children's Hospital of Zhejiang University School of Medicine
Frequently Asked Questions
Who can join the NCT07450872 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07450872 currently recruiting?
Yes, NCT07450872 is actively recruiting participants. Contact the research team at tangyinbing@zju.edu.cn for enrollment information.
Where is the NCT07450872 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07450872 clinical trial?
NCT07450872 is sponsored by The Children's Hospital of Zhejiang University School of Medicine. The principal investigator is Jinhu Wang at The Children's Hospital of Zhejiang University School of Medicine. The trial plans to enroll 600 participants.
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