Impact of Congenital Heart Disease on the Prognosis of Childhood Hematological Neoplasms: A Multicenter Cohort Study

Fudan University

Status: Completed

Conditions: Hematologic Malignancy; Congenital Heart Disease (CHD)

Study type: Observational

Funder types: Other

Identifiers

NCT07249138

CHOPA0012-CHFUCHD-2023

Details and patient eligibility

About

This study aims to determine whether congenital heart disease increases chronic health risks and mortality in childhood hematological tumor survivors, explore potential shared genetic factors between these conditions, identify other factors affecting long-term outcomes and quality of life, and validate any discovered genetic links through mechanistic investigations.

Full description

Children with congenital heart disease have a significantly higher risk of developing hematological tumors compared to the general pediatric population, although the clinical characteristics and prognosis of such comorbid cases have previously lacked systematic investigation. The study is set to include children with comorbid congenital heart disease and hematological tumors, comparing them with those without congenital heart disease, to conduct a detailed analysis of their clinical data, treatment responses, and survival outcomes.

Enrollment: 800 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children with hematologic malignancies diagnosed by pathology or bone marrow aspiration/biopsy at member hospitals of the Hematologic Oncology Specialty Alliance between 2010 and 2025;
2. Aged 0-17 years at diagnosis, regardless of gender;
3. Completed standard treatment for hematologic malignancies and confirmed diagnosis of congenital heart disease by cardiac ultrasound and clinical evaluation;
4. Written informed consent can be provided by the child or their legal guardian.

Exclusion criteria

1. Presence of birth defects other than congenital heart disease;
2. Other serious cardiac conditions, malignancies, or comorbidities that may interfere with study results;
3. Inability to provide the information and data required for the study.

Trial design

800 participants in 2 patient groups

Cohort of pediatric patients with congenital heart disease and hematological tumors

Cohort of pediatric patients with hematological tumors