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Clinical Trial NCT07483749 for Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoma, Leukemia, Pediatric is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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HEM-SURVIVE: Structuralized Follow-up for Childhood Hematological Malignancy Survivors 400
Clinical Trial NCT07483749 is an observational study for Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoma, Leukemia, Pediatric and is currently not yet recruiting. Enrollment is planned to begin on 25 March 2026 and continue until the study accrues 400 participants. Led by The Children's Hospital of Zhejiang University School of Medicine, this study is expected to complete by 1 December 2028. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
Brief Summary
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, standa...Show More
Official Title
A Multicenter Prospective Study on Structuralized Follow-up Model Construction and Late Effect Burden of Childhood Hematological Malignancy Survivors (HEM-SURVIVE)
Conditions
Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaLymphomaLeukemiaPediatricOther Study IDs
- 2026-IRB-0014-P-01
NCT ID Number
Start Date (Actual)
2026-03-25
Last Update Posted
2026-03-19
Completion Date (Estimated)
2028-12
Enrollment (Estimated)
400
Study Type
Observational
Status
Not yet recruiting
Keywords
Survivorship
Late Effects
Follow-up Model,
Risk Stratification
Late Effects
Follow-up Model,
Risk Stratification
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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. | N/A |
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. | N/A |
Primary Outcome Measures
| Outcome Measure | 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). |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
1 Year
Eligible Sexes
All
- 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.
- Severe organ failure preventing follow-up.
- Major genetic or systemic diseases affecting growth/organ function.
- Expected poor compliance or refusal to participate.
The Children's Hospital of Zhejiang University School of Medicine- Ningbo Women & Children's Hospital
- Hangzhou Children's Hospital
Study Responsible Party
zhangjingying, Principal Investigator, Principal Investigator, The Children's Hospital of Zhejiang University School of Medicine
Study Central Contact
Contact: Jingying Zhang, MD, +86 571 86670076, [email protected]
Contact: Tian Xia, MD, +86 15267035696, [email protected]
3 Study Locations in 1 Countries
Zhejiang
Children's hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China
Jing ying Zhang, MD, Contact, 86-15968103802, [email protected]
Tian Xia, MD, Contact, 86-15267035696, [email protected]
Jing ying Zhang, MD, Principal Investigator
Hangzhou Children's Hospital, Hangzhou, Zhejiang, 310014, China
Jing Huang, MD, Contact, 86-15968103802, [email protected]
Tian Xia, MD, Contact, 86-15267035696, [email protected]
Jing Huang, MD, Sub-Investigator
Affiliated Women and Children's Hospital of Ningbo University, Ningbo, Zhejiang, 315000, China
Jian hua Feng, MD, Contact, 86-15968103802, [email protected]
Tian Xia, MD, Contact, 86-15267035696, [email protected]
Jian hua Feng, MD, Sub-Investigator