Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors

NCT07450872 | Recruiting DMC

• 2 other identifiers: 2025-IRB-0350CHZJU2025IIT014
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Glioma; Leukemia (Both ALL and AML)

Keywords

symptom cluster; childhood cancer survivors; gut microbiat

Outcome Measures

Primary Outcomes (1)

• Symptom Cluster Severity and Structure in Childhood Cancer Survivors

  Symptom clusters will be assessed using validated patient-reported outcome instruments measuring fatigue, pain, sleep disturbance, depression, and related symptoms. Latent growth mixture modeling and network analysis will be used to identify cluster structures, severity levels, and longitudinal trajectories. Higher scores indicate greater symptom burden and more severe clustering patterns.

  Baseline, 3 months, and 6 months after enrollment

Study Arms (1)

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.

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will recruit childhood cancer survivors (CCS) aged 8-18 years and their primary caregivers. Eligible CCS have a clinically confirmed diagnosis of cancer (including leukemia, lymphoma, central nervous system tumors, and other common solid tumors) and are in the rehabilitation/maintenance phase or have completed treatment ≥6 months prior to enrollment. Participants must have no cognitive impairment and be able to understand, communicate, and complete assessments. Primary caregivers aged ≥20 years who provide daily care for eligible CCS will also be included. All participants will provide informed consent/assent. This cohort captures diverse cancer types and survivorship stages to examine symptom clusters, their longitudinal trajectories, and related psychosocial and biological factors, including gut microbiota and metabolites.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Fujian Maternity and Child Health Hospital: collaborator
• Jiangxi Province Children's Hospital: collaborator
• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310057, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal specimen

MeSH Terms

Conditions

Neoplasms; Glioma; Leukemia; Leukemia, Myeloid, Acute; Syndrome

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jinhu Wang

  The Children's Hospital of Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Jinhu Wang, Doctor of Medicine

CONTACT

86+13606636547; tangyinbing@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-01

Locations

CN (1)