Clinical trial · Observational
HEM-SURVIVE: Structuralized Follow-up for Childhood Hematological Malignancy Survivors
A Multicenter Prospective Study on Structuralized Follow-up Model Construction and Late Effect Burden of Childhood Hematological Malignancy Survivors (HEM-SURVIVE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Pediatric | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- HEM-SURVIVE Structured Follow-up Mode
- description
- Implementation of a structured follow-up system based on exposure-oriented risk stratification (four levels: Minimal, Standard, High, and Ultra-high risk). It includes standardized examination packages (A, A+, B, and C), multidisciplinary (MDT) survivor clinics, and digital management via the HEM-SURVIVE APP.
- label
- Conventional Follow-up Mode
- description
- Routine follow-up practices currently used in China. Examination projects are determined empirically by the attending physician and family, which lacks a unified path and systematic proactive monitoring. Key examinations for late effects are often triggered only after symptoms appear.
Primary outcomes (2)
- measure
- Incidence of severe late-effect composite endpoint.
- timeFrame
- From the date of enrollment to the end of follow-up (up to 36 months).
- description
- The incidence of grade 3-5 chronic health conditions, including severe cardiovascular events (e.g., heart failure), new-onset diabetes, pathological fractures, severe cognitive/psychological impairment, and second primary malignancies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available