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Symptoms and gut bacteria in children who survived cancer

Studies symptoms and gut bacteria in children who survived cancer.

Key facts

Who runs it
The Children's Hospital of Zhejiang University School of Medicine
Where
Hangzhou, ChinaSee the site
Trial code
Registry title
Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors
Status
Recruiting
People taking part
600 people, planned
Started
1 Jan 2026
Expected to end
31 Dec 2028
Type of study
Observational
Record updated
5 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 8-18 who had cancer and are in the rehabilitation or maintenance phase, or finished treatment at least 6 months ago. Their main caregivers can also take part.

Age
Children: 8-18 years. Caregivers: 20 years or older.
Sex
All sexes can join.
Disease stage
Cancer confirmed by clinical and pathology tests (including leukemia, lymphoma, central nervous system tumors, or other common solid tumors). Now in the rehabilitation or maintenance phase, or treatment finished at least 6 months before joining.
Earlier treatment
Treatment must be finished at least 6 months ago, or the child must be in the rehabilitation or maintenance phase. No new chemotherapy or radiotherapy planned during the study.

Main reasons for not taking part

  • Severe late effects of treatment, such as significant organ problems or nerve damage, that could disturb symptom assessment
  • Cannot complete the interviews or questionnaires alone
  • Taking part in another interventional trial that may affect the results
  • Major surgery planned during the study
  • Caregivers: major life events in the past 6 months, such as bereavement or divorce

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 8 and 18 years old?

Where in China

  • Children's Hospital, Zhejiang University School of MedicineHangzhou, ChinaContact: Jinhu Wang, Doctor of MedicineTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Childhood Cancer Survivors and Their Primary Caregivers

    This cohort includes children aged 8-18 years diagnosed with cancer (leukemia, lymphoma, CNS tumors, or common solid tumors) who have completed active treatment or are in maintenance/recovery for ≥6 months. Eligible children must have normal cognitive and communication abilities. Primary caregivers are adults aged ≥ 20 years who provide main care and can complete assessments. Exclusion criteria include severe treatment-related complications, cognitive or communication impairments, inability to complete study procedures independently, recent major life events for caregivers, or concurrent interventions affecting outcomes. No interventions are applied; this is an observational study. Data collection includes repeated symptom assessments and stool sample analysis to explore gut microbiota and metabolite associations with symptom clusters.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multicenter Study on the Heterogeneity of Symptom Clusters and the Underlying Mechanisms of Gut Microbiota and Metabolites Among Childhood Cancer Survivors
Plain-language title
Symptoms and gut bacteria in children who survived cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07450872, who can take part
Record updated
5 June 2026