Skip to main content
OpenTrials
Completed

NCT Number: NCT07249138

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

0 week–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Children's Hospital, Beijing, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Occurrence of all-cause death

    Time frame: from enrollment to follow-up for 5 year

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

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

Registry information

Official study title

Impact of Congenital Heart Disease on Quality of Life and Long-Term Outcomes in Childhood Hematological Tumor Survivors

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

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.

Published trials that share one or more normalized conditions with this study.