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)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07483749

Enrollment

400

Registered

2026-03-19

Start date

2026-03-25

Completion date

2028-12-01

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Leukemia, Lymphoma, Pediatric

Keywords

Survivorship, Late Effects, Follow-up Model,, Risk Stratification

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, 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 21 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of severe late-effect composite endpoint.	From the date of enrollment to the end of follow-up (up to 36 months).	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.
Compliance rate of the structured follow-up mode.	Throughout the study period (24-36 months).	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%.

Countries

China

Contacts

CONTACTJingying Zhang, MD

zhangjy423@zju.edu.cn+86 571 86670076

CONTACTTian Xia, MD

xiatian0604@zju.edu.cn+86 15267035696

Outcome results