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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.
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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Jingying Zhang, MD

CONTACT

[email protected]

+86 571 86670076

Tian Xia, MD

CONTACT

[email protected]

+86 15267035696

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Collaborators

Hangzhou Children's Hospital
Ningbo Women & Children's Hospital

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Mar 19, 2026
Registry last updated: Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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