Congenital Heart Disease (CHD), Hematologic Malignancy
Conditions
Brief summary
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.
Detailed 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.
Interventions
None listed
Sponsors
Nanjing Children's Hospital
Children's Hospital of Suzhou University
Tongji Hospital
Shandong Provincial Hospital
Guangzhou Women and Children's Medical Center
Wuhan Children's Hospital
Union Hospital of Huazhong University of Science and Technology
The Third Xiangya Hospital of Central South University
Inner Mongolia Maternal and Child Health Care Hospital
The First Affiliated Hospital of Zhengzhou University
Beijing Children's Hospital
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Shanxi Provincial Maternity and Children's Hospital
The Affiliated Hospital of Qingdao University
Shanghai Children's Hospital
First Affiliated Hospital of Guangxi Medical University
Hebei Medical University Fourth Hospital
Children's Hospital of Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Weeks to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of all-cause death | from enrollment to follow-up for 5 year | — |
| Frequency and severity of SAEs assessed by CTCAE v5.0 | from enrollment to follow-up for 5 year | CommonTerminology Criteria for Adverse Events（CTCAE）has 5 levels of AE determination, increasing in severity as the level increases |
Countries
China
Outcome results
None listed