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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-21
SponsorThe Children's Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Severe organ failure preventing follow-up.

Major genetic or systemic diseases affecting growth/organ function.

Expected poor compliance or refusal to participate.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: HEM-SURVIVE Structured Follow-up Mode
Group B: Conventional Follow-up Mode

Trial outcomes

Primary outcomes

1

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).
2

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).

Secondary outcomes

Other outcomes

Sponsors and contacts

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The Children's Hospital of Zhejiang University School of Medicine

Lead sponsor

Ningbo Women & Children's Hospital

Collaborator

Hangzhou Children's Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: