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

NCT ID: NCT07249138

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-11-10

Brief Summary

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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

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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.

Conditions

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Congenital Heart Disease (CHD) Hematologic Malignancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort of pediatric patients with congenital heart disease and hematological tumors

No interventions assigned to this group

Cohort of pediatric patients with hematological tumors

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

0 Weeks

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Suzhou University

UNKNOWN

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Wuhan Children's Hospital

OTHER

Sponsor Role collaborator

Union Hospital of Huazhong University of Science and Technology

UNKNOWN

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Inner Mongolia Maternal and Child Health Care Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Beijing Children's Hospital

OTHER

Sponsor Role collaborator

Northwest Women's and Children's Hospital, Xi'an, Shaanxi

OTHER

Sponsor Role collaborator

Shanxi Provincial Maternity and Children's Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

Shanghai Children's Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Children's Hospital

Beijing, , China

Site Status

The Third Xiangya Hospital of Central South University

Changsha, , China

Site Status

Guangzhou Women and Children's Medical Center

Guangzhou, , China

Site Status

Inner Mongolia Maternal and Child Health Care Hospital

Hohhot, , China

Site Status

Shandong Provincial Hospital

Jinan, , China

Site Status

Nanjing Children's Hospital

Nanjing, , China

Site Status

The First Affiliated Hospital of Guangxi Medical University

Nanning, , China

Site Status

The Affiliated Hospital of Qingdao University

Qingdao, , China

Site Status

Children's Hospital of Fudan University

Shanghai, , China

Site Status

Shanghai Children's HospitalShanghai Children's Hospital

Shanghai, , China

Site Status

The Fourth Hospital of Hebei Medical University

Shijiazhuang, , China

Site Status

Children's Hospital of Soochow University

Suzhou, , China

Site Status

Shanxi Children's Hospital

Taiyuan, , China

Site Status

Tongji Hospital of Huazhong University of Science and Technology

Wuhan, , China

Site Status

Union Hospital of Huazhong University of Science and Technology

Wuhan, , China

Site Status

Wuhan Children's Hospital

Wuhan, , China

Site Status

Northwest Women's and Children's Hospital

Xi'an, , China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status

Countries

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China

Other Identifiers

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CHOPA0012-CHFUCHD-2023

Identifier Type: -

Identifier Source: org_study_id

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