NCT07483749

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

March 2, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 19, 2026

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

March 2, 2026

Last Update Submit

March 17, 2026

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaLymphomaLeukemiaPediatric

Keywords

SurvivorshipLate EffectsFollow-up Model,Risk Stratification

Outcome Measures

Primary Outcomes (2)

  • 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).

Study Arms (2)

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.

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • Severe organ failure preventing follow-up.
  • Major genetic or systemic diseases affecting growth/organ function.
  • Expected poor compliance or refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Hangzhou Children's Hospital

Hangzhou, Zhejiang, 310014, China

Location

Affiliated Women and Children's Hospital of Ningbo University

Ningbo, Zhejiang, 315000, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLymphomaLeukemia

Condition Hierarchy (Ancestors)

Leukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myeloid

Central Study Contacts

Jingying Zhang, MD

CONTACT

+86 571 86670076zhangjy423@zju.edu.cn

Tian Xia, MD

CONTACT

+86 15267035696xiatian0604@zju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 19, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 19, 2026

Record last verified: 2025-12

Locations

CN(3)