HEM-SURVIVE: Structuralized Follow-up for Childhood Hematological Malignancy Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoma, Leukemia. Basic parameters: 1 year — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Prospective Study on Structuralized Follow-up Model Construction and Late Effect Burden of Childhood Hematological Malignancy Survivors (HEM-SURVIVE)
Overview
This study aims to construct a structuralized follow-up model for survivors of childhood hematological malignancies in China. Using a multicenter prospective cohort design, it will identify the burden and risk factors of late effects. The study hypothesizes that a standardized follow-up path managed by an electronic platform will improve follow-up compliance and reduce the missed diagnosis rate of late effects.
Detailed description
This multicenter, prospective cohort study is designed to evaluate the effectiveness of a structuralized follow-up model (HEM-SURVIVE) for childhood hematological malignancy survivors in China. Currently, follow-up practices lack a standardized pathway. This study will enroll 400 eligible survivors (aged 1-21 years) and assign them into two cohorts: the structured follow-up mode (utilizing risk stratification, standardized examination packages, MDT clinics, and a dedicated mobile APP) and the conventional follow-up mode. The study aims to accurately assess the burden of late effects (such as cardiovascular events, endocrine disorders, and secondary malignancies) and to determine whether the structured electronic pathway improves patient compliance and early detection rates compared to routine empirical follow-up over a 36-month period.
Primary outcome measures
- Incidence of severe late-effect composite endpoint. [Time frame: From the date of enrollment to the end of follow-up (up to 36 months).]
- Compliance rate of the structured follow-up mode. [Time frame: Throughout the study period (24-36 months).]
Eligibility criteria
Inclusion criteria
- Diagnosed with childhood hematological malignancies (ALL, AML, Lymphoma, etc.), Completed primary treatment for ≥12 months.
- Age 1-21 years.
- Capable of completing follow-up and data collection.
- Informed consent signed.
Exclusion criteria
- Severe organ failure preventing follow-up.
- Major genetic or systemic diseases affecting growth/organ function.
- Expected poor compliance or refusal to participate.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 3 centers
- Children's hospital, Zhejiang University School of Medicine — Hangzhou
- Hangzhou Children's Hospital — Hangzhou
- Affiliated Women and Children's Hospital of Ningbo University — Ningbo
Identifiers
NCT: NCT07483749 · 2026-IRB-0014-P-01