Congenital Heart Disease (CHD)NCT07249138
Impact of Congenital Heart Disease on the Prognosis of Childhood Hematological Neoplasms: A Multicenter Cohort Study
An observational study of Congenital Heart Disease (CHD) and Hematologic Malignancy, run by Children's Hospital of Fudan University at 18 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 weeks to 18 years
- Conditions the study is for
- Congenital Heart Disease (CHD), Hematologic Malignancy
- How many people
- 800 participants
- Where
- 18 sitesChina
- Study dates
- 15 Feb 2025to 10 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Beijing Children's Hospital
Beijing
The Third Xiangya Hospital of Central South University
Changsha
Guangzhou Women and Children's Medical Center
Guangzhou
Inner Mongolia Maternal and Child Health Care Hospital
Hohhot
Shandong Provincial Hospital
Jinan
Nanjing Children's Hospital
Nanjing
The First Affiliated Hospital of Guangxi Medical University
Nanning
The Affiliated Hospital of Qingdao University
Qingdao
Children's Hospital of Fudan University
Shanghai
Shanghai Children's HospitalShanghai Children's Hospital
Shanghai
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Children's Hospital of Soochow University
Suzhou
Shanxi Children's Hospital
Taiyuan
Tongji Hospital of Huazhong University of Science and Technology
Wuhan
Union Hospital of Huazhong University of Science and Technology
Wuhan
Wuhan Children's Hospital
Wuhan
Northwest Women's and Children's Hospital
Xi'an
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: Impact of Congenital Heart Disease on Quality of Life and Long-Term Outcomes in Childhood Hematological Tumor Survivors
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.
Read the 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.
- Medical subject headings
- Heart Defects, Congenital, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of pediatric patients with congenital heart disease and hematological tumors | Not described | |
| Cohort of pediatric patients with hematological tumors | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of all-cause death
Measured: 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
Measured: from enrollment to follow-up for 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 Feb 2025
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Tongji Medical College, 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249138
- Sponsor's protocol ID
- CHOPA0012-CHFUCHD-2023
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Congenital Heart Disease on Quality of Life and Long-Term Outcomes in Childhood Hematological Tumor Survivors
- ClinicalTrials.gov ID
- NCT07249138
- Acronym / sponsor ID
- CHOPA0012-CHFUCHD-2023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- 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, Tongji Medical College, 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
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort of pediatric patients with congenital heart disease and hematological tumors | – | – |
| Cohort of pediatric patients with hematological tumors | – | – |
Who may qualify
- Ages
- 0 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of all-cause death
Time frame: from enrollment to follow-up for 5 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease (CHD) and Hematologic Malignancy, run by Children's Hospital of Fudan University at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of all-cause death (time frame: from enrollment to follow-up for 5 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.