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O estudo clínico NCT07483749 para Leucemia linfoblástica aguda, Leucemia mieloide aguda, Linfoma, Leucemia, Pediátrico está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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HEM-SURVIVE: Structuralized Follow-up for Childhood Hematological Malignancy Survivors 400

Ainda não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07483749 é um estudo observacional para Leucemia linfoblástica aguda, Leucemia mieloide aguda, Linfoma, Leucemia, Pediátrico. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 25 de março de 2026, com o objetivo de incluir 400 participantes. Coordenado por The Children's Hospital of Zhejiang University School of Medicine e deve ser concluído em 1 de dezembro de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 19 de março de 2026.
Resumo
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.
Descrição detalhada
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, standa...Mostrar mais
Título oficial

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

Condições médicas
Leucemia linfoblástica agudaLeucemia mieloide agudaLinfomaLeucemiaPediátrico
Outros IDs do estudo
  • 2026-IRB-0014-P-01
Número NCT
NCT07483749
Data de início (real)
2026-03-25
Última atualização postada
2026-03-19
Data de conclusão (estimada)
2028-12
Inscrição (estimada)
400
Tipo de estudo
Observacional
Status
Ainda não recrutando
Palavras-chave
Survivorship
Late Effects
Follow-up Model,
Risk Stratification
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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.
N/A
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.
N/A
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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).
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Criança, Adulto
Idade mínima
1 Year
Sexos elegíveis
Todos
  • 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.

  • Severe organ failure preventing follow-up.
  • Major genetic or systemic diseases affecting growth/organ function.
  • Expected poor compliance or refusal to participate.
The Children's Hospital of Zhejiang University School of Medicine logoThe Children's Hospital of Zhejiang University School of Medicine
  • Ningbo Women & Children's Hospital logoNingbo Women & Children's Hospital
  • Hangzhou Children's Hospital logoHangzhou Children's Hospital
Responsável pelo estudo
zhangjingying, Investigador principal, Principal Investigator, The Children's Hospital of Zhejiang University School of Medicine
Contato central do estudo
Contato: Jingying Zhang, MD, +86 571 86670076, [email protected]
Contato: Tian Xia, MD, +86 15267035696, [email protected]
3 Locais do estudo em 1 países

Zhejiang

Children's hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China
Jing ying Zhang, MD, Contato, 86-15968103802, [email protected]
Tian Xia, MD, Contato, 86-15267035696, [email protected]
Jing ying Zhang, MD, Investigador principal
Hangzhou Children's Hospital, Hangzhou, Zhejiang, 310014, China
Jing Huang, MD, Contato, 86-15968103802, [email protected]
Tian Xia, MD, Contato, 86-15267035696, [email protected]
Jing Huang, MD, Subinvestigador
Affiliated Women and Children's Hospital of Ningbo University, Ningbo, Zhejiang, 315000, China
Jian hua Feng, MD, Contato, 86-15968103802, [email protected]
Tian Xia, MD, Contato, 86-15267035696, [email protected]
Jian hua Feng, MD, Subinvestigador