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

NCT07249138 | Completed

• 1 other identifier: CHOPA0012-CHFUCHD-2023
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 18

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.

Conditions

Congenital Heart Disease (CHD); Hematologic Malignancy

Outcome Measures

Primary Outcomes (2)

• Occurrence of all-cause death

  from enrollment to follow-up for 5 year

• Frequency and severity of SAEs assessed by CTCAE v5.0

  CommonTerminology Criteria for Adverse Events（CTCAE）has 5 levels of AE determination, increasing in severity as the level increases

  from enrollment to follow-up for 5 year

Study Arms (2)

Cohort of pediatric patients with congenital heart disease and hematological tumors

Cohort of pediatric patients with hematological tumors

Eligibility Criteria

• Age: 0 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise pediatric patients with hematological malignancies who also have congenital heart disease, identified through a multi-center collaborative network spanning major tertiary hospitals across China. This cohort will include children aged 0-18 years at diagnosis who were treated between 2010 and 2025, with detailed clinical data collected retrospectively from participating medical institutions. The selection specifically focuses on patients who completed standard oncologic treatment and received confirmed congenital heart disease diagnoses through comprehensive cardiac evaluation.

You may qualify if:

• 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;
• Aged 0-17 years at diagnosis, regardless of gender;
• Completed standard treatment for hematologic malignancies and confirmed diagnosis of congenital heart disease by cardiac ultrasound and clinical evaluation;
• Written informed consent can be provided by the child or their legal guardian.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Nanjing Children's Hospital: collaborator
• Children's Hospital of Suzhou University: collaborator
• Tongji Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• Guangzhou Women and Children's Medical Center: collaborator
• Wuhan Children's Hospital: collaborator
• Union Hospital of Huazhong University of Science and Technology: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Inner Mongolia Maternal and Child Health Care Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Beijing Children's Hospital: collaborator
• Northwest Women's and Children's Hospital, Xi'an, Shaanxi: collaborator
• Shanxi Provincial Maternity and Children's Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Shanghai Children's Hospital: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Hebei Medical University Fourth Hospital: collaborator

Study Sites (18)

Beijing Children's Hospital

Beijing, China

Location

The Third Xiangya Hospital of Central South University

Changsha, China

Location

Guangzhou Women and Children's Medical Center

Guangzhou, China

Location

Inner Mongolia Maternal and Child Health Care Hospital

Hohhot, China

Location

Shandong Provincial Hospital

Jinan, China

Location

Nanjing Children's Hospital

Nanjing, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, China

Location

Children's Hospital of Fudan University

Shanghai, China

Location

Shanghai Children's HospitalShanghai Children's Hospital

Shanghai, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, China

Location

Children's Hospital of Soochow University

Suzhou, China

Location

Shanxi Children's Hospital

Taiyuan, China

Location

Tongji Hospital of Huazhong University of Science and Technology

Wuhan, China

Location

Union Hospital of Huazhong University of Science and Technology

Wuhan, China

Location

Wuhan Children's Hospital

Wuhan, China

Location

Northwest Women's and Children's Hospital

Xi'an, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone Marrow Mononuclear Cells (BMMCs) in TRIzol (-80°C) Serum and Plasma aliquots (-80°C) Peripheral Blood Mononuclear Cells (PBMCs) (-80°C or in liquid nitrogen) Genomic DNA from blood or bone marrow (-80°C) Genomic RNA from blood or bone marrow (-80°C)

MeSH Terms

Conditions

Heart Defects, Congenital; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: February 15, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

CN (18)