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

March 17, 2026 updated by: zhangjingying, The Children's Hospital of Zhejiang University School of Medicine

A Multicenter Prospective Study on Structuralized Follow-up Model Construction and Late Effect Burden of Childhood Hematological Malignancy Survivors (HEM-SURVIVE)

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jingying Zhang, MD
Phone Number: +86 571 86670076
Email: zhangjy423@zju.edu.cn

Study Contact Backup

Name: Tian Xia, MD
Phone Number: +86 15267035696
Email: xiatian0604@zju.edu.cn

Study Locations

China
- Zhejiang
  - Hangzhou, Zhejiang, China, 310000
    - Children's Hospital, Zhejiang University School of Medicine
    - Contact:
      
      Jing ying Zhang, MD
      
      Phone Number: 86-15968103802
      
      Email: zhangjy423@zju.edu.cn
    - Contact:
      
      Tian Xia, MD
      
      Phone Number: 86-15267035696
      
      Email: xiatian0604@zju.edu.cn
    - Principal Investigator:
      
      Jing ying Zhang, MD
  - Hangzhou, Zhejiang, China, 310014
    - Hangzhou Children's Hospital
    - Contact:
      
      Tian Xia, MD
      
      Phone Number: 86-15267035696
      
      Email: xiatian0604@zju.edu.cn
    - Contact:
      
      Jing Huang, MD
      
      Phone Number: 86-15968103802
      
      Email: zhangjy423@zju.edu.cn
    - Sub-Investigator:
      
      Jing Huang, MD
  - Ningbo, Zhejiang, China, 315000
    - Affiliated Women and Children's Hospital of Ningbo University
    - Contact:
      
      Tian Xia, MD
      
      Phone Number: 86-15267035696
      
      Email: xiatian0604@zju.edu.cn
    - Contact:
      
      Jian hua Feng, MD
      
      Phone Number: 86-15968103802
      
      Email: zhangjy423@zju.edu.cn
    - Sub-Investigator:
      
      Jian hua Feng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Collaborators

Ningbo Women & Children's Hospital

Hangzhou Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 25, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)