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| Name | Class |
|---|---|
| Ningbo Women & Children's Hospital | OTHER |
| Hangzhou Children's Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEM-SURVIVE Structured Follow-up Mode | 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. | ||
| Conventional Follow-up Mode | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe late-effect composite endpoint. | 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. | From the date of enrollment to the end of follow-up (up to 36 months). |
| Compliance rate of the structured follow-up mode. | The percentage of participants who complete the scheduled follow-up visits and examinations according to their assigned risk level. The target compliance rate is ≥80%. | Throughout the study period (24-36 months). |
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Inclusion Criteria:
Exclusion Criteria:
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Long-term survivors of childhood hematological malignancies (including ALL, AML, and lymphoma) who have completed primary treatment for at least 12 months and are in complete remission (CR).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingying Zhang, MD | Contact | +86 571 86670076 | zhangjy423@zju.edu.cn | |
| Tian Xia, MD | Contact | +86 15267035696 | xiatian0604@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| Hangzhou Children's Hospital | Hangzhou | Zhejiang | 310014 | China |
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| Affiliated Women and Children's Hospital of Ningbo University | Ningbo | Zhejiang | 315000 | China |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |