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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Children's Hospital, Zhejiang University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jing ying Zhang, MD
      • Hangzhou, Zhejiang, China, 310014
        • Hangzhou Children's Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jing Huang, MD
      • Ningbo, Zhejiang, China, 315000
        • Affiliated Women and Children's Hospital of Ningbo University
        • Contact:
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Children's Hospital of Zhejiang University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-IRB-0014-P-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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