Actively Recruiting

Age: 8Years - 18Years
All Genders
NCT07450872

Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors

Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2026-03-05

600

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

T

The Children's Hospital of Zhejiang University School of Medicine

Lead Sponsor

F

Fujian Maternity and Child Health Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors

Who Can Participate

Age: 8Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 8 to 18 years
  • Clinically and pathologically confirmed diagnosis of cancer including leukemia, lymphoma, central nervous system tumors, or other common solid tumors
  • Currently in rehabilitation or maintenance phase, or completed treatment at least 6 months before enrollment
  • No cognitive impairment; able to understand, communicate, and complete questionnaires independently
  • Written informed consent/assent obtained from participants and their legal guardians
Not Eligible

You will not qualify if you...

  • Presence of severe treatment-related sequelae such as significant organ dysfunction or neurological impairment that may interfere with symptom assessment
  • Poor compliance or inability to complete interviews or questionnaires independently
  • Concurrent participation in other interventional clinical trials that may affect study outcomes
  • Planned major surgery or new chemotherapy/radiotherapy during the study period
  • For caregivers: major adverse life events in past 6 months affecting psychological assessment
  • Severe cognitive impairment, aphasia, psychiatric disorders, or other conditions preventing independent completion of assessments

AI-Screening

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Trial Site Locations

Total: 1 location

1

Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310057

Actively Recruiting

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Research Team

J

Jinhu Wang, Doctor of Medicine

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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