NCT07450872Recruiting
Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms 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
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 27 Feb 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT07450872
What you commit to
- Study type: Observational
- Planned participants: 600
- From 1 Jan 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Presence of severe treatment-related sequelae (e.g., significant organ dysfunction or neurological impairment) that may interfere with symptom assessment;
- Presence of severe cognitive impairment;
- Presence of severe aphasia, psychiatric disorders, or other conditions preventing independent completion of assessments.
Other
- Poor compliance or inability to independently complete interviews/questionnaires;
- Experience of major adverse life events within the past 6 months (e.g., bereavement, divorce) that may affect psychological assessment
Who the study is looking for
- 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.
- 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.
Age in the registry: 8 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.