HEM-SURVIVE: Structuralized Follow-up for Childhood Hematological Malignancy Survivors

N/ANot Yet RecruitingNCT07483749

The Children's Hospital of Zhejiang University School of Medicine400 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Lymphoma Leukemia

Eligibility

Sex: ALLMin age: 1 YearMax age: 21 Years

Medical Language ↔ Plain English

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.

Locations (3)

Children's hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Hangzhou Children's Hospital

Hangzhou, Zhejiang, China

Affiliated Women and Children's Hospital of Ningbo University

Ningbo, Zhejiang, China

Outcomes

Primary Outcomes

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.

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.

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%.

Time frame: Throughout the study period (24-36 months).