CancerSC-Het-GM-CCSNCT07450872
Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors
An observational study of Cancer and Glioma, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cancer, Glioma, Leukemia (Both ALL and AML)
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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;
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- 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 join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310057
Jinhu Wang, Doctor of Medicine, 86+13606636547, wangjinhu@zju.edu.cn
About this study
Official title: A Multicenter Study on the Heterogeneity of Symptom Clusters and the Underlying Mechanisms of Gut Microbiota and Metabolites Among Childhood Cancer Survivors
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.
Read more
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.
Read the detailed description
Background
Advances in diagnostic and therapeutic strategies have markedly improved survival among children with cancer. In high-income regions, the 5-year net survival rate for common childhood cancers has reached 80% to 95%, while in China the overall 5-year relative survival rate is approximately 71.9%. As survival improves, the number of childhood cancer survivors (CCS) continues to increase. However, the long-term impact of cancer and its treatment remains substantial.
Cancer treatments, including chemotherapy, radiotherapy, surgery, and targeted immunotherapy, may lead to a wide range of persistent physical and psychological symptoms. CCS often experience multiple concurrent symptoms, such as fatigue, pain, sleep disturbance, depression, and nausea. These symptoms frequently co-occur and interact, forming symptom clusters that may exacerbate overall symptom burden and negatively affect treatment outcomes, health-related quality of life, and long-term prognosis.
Symptom clusters have been widely reported across different cancer types and treatment stages. Despite observed heterogeneity, core symptom clusters-particularly physical, gastrointestinal, and psychological clusters-demonstrate relative stability across studies and over time. Longitudinal evidence suggests that while the number and composition of symptom clusters may vary, core clusters persist across treatment phases, indicating potential underlying biological mechanisms.
In addition to psychosocial factors, emerging evidence highlights the role of the gut microbiota and its metabolites in influencing host physiology and symptom expression. The gut microbiota interacts with the host through metabolic, immune, and neuroendocrine pathways, and may contribute to symptom heterogeneity via interconnected systems such as the gut-brain axis. Chemotherapy-induced inflammation and intestinal barrier disruption may further mediate these processes, suggesting a potential biological basis for persistent symptom clusters in CCS.
Rationale
Although symptom clusters in CCS have been increasingly studied, several critical gaps remain. First, most existing studies rely on cross-sectional data or short-term follow-up, limiting the ability to assess the long-term stability of symptom clusters. Second, research is often restricted to single cancer types or treatment stages, lacking comprehensive evaluation across diseases and treatment trajectories. Third, the identification of core symptoms and clusters is often inconsistent, with limited use of quantitative indicators to assess stability across time.
Furthermore, while psychosocial factors have been explored, the biological mechanisms underlying symptom clusters remain insufficiently understood. In particular, prospective evidence linking gut microbiota, metabolites, and symptom clusters in pediatric cancer populations is scarce. Existing studies are often limited to animal models or single biological pathways, and do not capture the complex interactions within the microbiota-immune-neuro network.
Addressing these gaps is essential for improving the understanding of symptom cluster heterogeneity and stability, and for identifying potential targets for intervention. A comprehensive approach integrating longitudinal symptom assessment with microbiome and metabolomic data may provide novel insights into the mechanisms underlying symptom clusters in CCS.
Objectives
The primary objective of this study is to characterize the heterogeneity and stability of symptom clusters among childhood cancer survivors and to explore their underlying mechanisms.
The specific objectives are:
- To identify and classify symptom clusters in CCS across different cancer types and treatment stages
- To examine the longitudinal stability of core symptom clusters using repeated measurements at baseline, 3 months, and 6 months
- To analyze the associations between symptom clusters and gut microbiota composition and metabolite profiles
- To explore the potential biological mechanisms linking gut microbiota-metabolite alterations with symptom cluster development
This study aims to provide evidence for a more comprehensive understanding of symptom burden in CCS and to inform the development of targeted, mechanism-based symptom management strategies.
- Conditions
- Cancer, Glioma, Leukemia (Both ALL and AML)
- Keywords
- symptom cluster, childhood cancer survivors, gut microbiat
- Medical subject headings
- Neoplasms, Glioma, Leukemia, Leukemia, Myeloid, Acute, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Maternity and Child Health Hospital, Jiangxi Province Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Jinhu Wang, Study chair, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450872
- Sponsor's protocol ID
- 2025-IRB-0350
- Other IDs
- CHZJU2025IIT014
- Acronym
- SC-Het-GM-CCS
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not yet determined whether individual participant data (IPD) will be shared because the dataset includes sensitive information from children and their parents, as well as biological data (e.g., microbiome data), which raises privacy and ethical considerations. Decisions regarding data sharing will depend on institutional policies, ethical approvals, and the development of appropriate data protection and de-identification procedures.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on the Heterogeneity of Symptom Clusters and the Underlying Mechanisms of Gut Microbiota and Metabolites Among Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT07450872
- Acronym / sponsor ID
- SC-Het-GM-CCS / 2025-IRB-0350
- Conditions
- Cancer, Glioma, Leukemia (Both ALL and AML)
- Keywords
- symptom cluster, childhood cancer survivors, gut microbiat
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Fujian Maternity and Child Health Hospital, Jiangxi Province Children's Hospital
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
Advances in diagnostic and therapeutic strategies have markedly improved survival among children with cancer. In high-income regions, the 5-year net survival rate for common childhood cancers has reached 80% to 95%, while in China the overall 5-year relative survival rate is approximately 71.9%. As survival improves, the number of childhood cancer survivors (CCS) continues to increase. However, the long-term impact of cancer and its treatment remains substantial.
Cancer treatments, including chemotherapy, radiotherapy, surgery, and targeted immunotherapy, may lead to a wide range of persistent physical and psychological symptoms. CCS often experience multiple concurrent symptoms, such as fatigue, pain, sleep disturbance, depression, and nausea. These symptoms frequently co-occur and interact, forming symptom clusters that may exacerbate overall symptom burden and negatively affect treatment outcomes, health-related quality of life, and long-term prognosis.
Symptom clusters have been widely reported across different cancer types and treatment stages. Despite observed heterogeneity, core symptom clusters-particularly physical, gastrointestinal, and psychological clusters-demonstrate relative stability across studies and over time. Longitudinal evidence suggests that while the number and composition of symptom clusters may vary, core clusters persist across treatment phases, indicating potential underlying biological mechanisms.
In addition to psychosocial factors, emerging evidence highlights the role of the gut microbiota and its metabolites in influencing host physiology and symptom expression. The gut microbiota interacts with the host through metabolic, immune, and neuroendocrine pathways, and may contribute to symptom heterogeneity via interconnected systems such as the gut-brain axis. Chemotherapy-induced inflammation and intestinal barrier disruption may further mediate these processes, suggesting a potential biological basis for persistent symptom clusters in CCS.
Rationale
Although symptom clusters in CCS have been increasingly studied, several critical gaps remain. First, most existing studies rely on cross-sectional data or short-term follow-up, limiting the ability to assess the long-term stability of symptom clusters. Second, research is often restricted to single cancer types or treatment stages, lacking comprehensive evaluation across diseases and treatment trajectories. Third, the identification of core symptoms and clusters is often inconsistent, with limited use of quantitative indicators to assess stability across time.
Furthermore, while psychosocial factors have been explored, the biological mechanisms underlying symptom clusters remain insufficiently understood. In particular, prospective evidence linking gut microbiota, metabolites, and symptom clusters in pediatric cancer populations is scarce. Existing studies are often limited to animal models or single biological pathways, and do not capture the complex interactions within the microbiota-immune-neuro network.
Addressing these gaps is essential for improving the understanding of symptom cluster heterogeneity and stability, and for identifying potential targets for intervention. A comprehensive approach integrating longitudinal symptom assessment with microbiome and metabolomic data may provide novel insights into the mechanisms underlying symptom clusters in CCS.
Objectives
The primary objective of this study is to characterize the heterogeneity and stability of symptom clusters among childhood cancer survivors and to explore their underlying mechanisms.
The specific objectives are:
- To identify and classify symptom clusters in CCS across different cancer types and treatment stages
- To examine the longitudinal stability of core symptom clusters using repeated measurements at baseline, 3 months, and 6 months
- To analyze the associations between symptom clusters and gut microbiota composition and metabolite profiles
- To explore the potential biological mechanisms linking gut microbiota-metabolite alterations with symptom cluster development
This study aims to provide evidence for a more comprehensive understanding of symptom burden in CCS and to inform the development of targeted, mechanism-based symptom management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Experience of major adverse life events within the past 6 months (e.g., bereavement, divorce) that may affect psychological assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom Cluster Severity and Structure in Childhood Cancer Survivors
Time frame: Baseline, 3 months, and 6 months after enrollment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Undecided. We have not yet determined whether individual participant data (IPD) will be shared because the dataset includes sensitive information from children and their parents, as well as biological data (e.g., microbiome data), which raises privacy and ethical considerations. Decisions regarding data sharing will depend on institutional policies, ethical approvals, and the development of appropriate data protection and de-identification procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinhu Wang study chair
The Children's Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Glioma, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinhu Wang, Doctor of Medicine (86+13606636547, tangyinbing@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Cluster Severity and Structure in Childhood Cancer Survivors (time frame: Baseline, 3 months, and 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.