Hematopoietic Stem Cell TransplantationCORE-HCTNCT07349498
Cardiovascular Outcomes and Risk Evaluation Among Recipients of Hematopoietic Stem Cell Transplantation
An observational study of Hematopoietic Stem Cell Transplantation and Transplant Complication, run by Peking University People's Hospital at 16 sites in China.
Trial summary
This is a prospective, multicenter observational study for recipients of hematopoietic stem cell transplantation. Patients who underwent hematopoietic stem cell transplantation at the participating centers will be entrolled in the study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Transplant Complication, Cardiovascular Events
- How many people
- 10,000 participants
- Where
- 16 sitesChina
- Study dates
- 1 Jan 2026to 31 Dec 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who undergo hematopoietic cell transplantation at any of the participating medical centers.
Who may be able to join
- Patients who undergo hematopoietic cell transplantation at any of the participating medical centers.
Who cannot join
- Any other conditions that, in the opinion of the investigator, can interfere with the interpretation of data.
- Patient request to withdraw from the study.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Dai Hong Liu
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Yu Jun Dong
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Xiao Hui Zhang, 861088324577, zhangxh@bjmu.edu.cn
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Hong Mei Jing
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Xiao Bing Huang
- Recruiting
Xinqiao hospital of the third military medical university
Chongqing, Chongqing Municipality
Xi Zhang
- Recruiting
Sun Yat-sen University Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong
Yang Liang
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Yi Luo
- Recruiting
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Sheng Jin Fan
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Hong Yu Zhang
- Recruiting
Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)
Tianjin, Tianjin Municipality
Er Lie Jiang
- Recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Ming Jiang
- Recruiting
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Yi Cheng Zhang
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Ling Hui Xia
- Recruiting
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi
Peng Cheng He
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zhong Xing Jiang
About this study
Official title: Cardiovascular Outcomes and Risk Evaluation Among Recipients of Hematopoietic Stem Cell Transplantation (CORE-HCT): A Prospective Multicenter Observational Study
This is a prospective, multicenter observational study for recipients of hematopoietic stem cell transplantation. Patients who underwent hematopoietic stem cell transplantation at the participating centers will be entrolled in the study. The clinical characteristics, laboratory profiles, management measures, and clinical outcomes such as post-transplant cardiovascular events will be prospectively collected.
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 |
|---|---|---|
| Patients undergoing hematopoietic stem cell transplantation | Patients who undergo allogeneic hematopoietic stem cell transplantation at participating medical center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
Major adverse cardiovascular events (MACE) after hematopoietic stem cell transplantation.
Measured: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Secondary outcomes (4)
Cardiovascular events
Cardiovascular events after hematopoietic stem cell transplantation, such as cardiovascular death, ischemic heart disease, coronary artery disease, stroke, heart failure, arrhythmia cardiomyopathy, myocarditis, endocarditis, valvular heart disease, and pericardial disease.
Measured: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Overall survival
Overall survival after hematopoietic stem cell transplantation.
Measured: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Event-free survival
Events were defined as the occurrence of any of the following after allo-HSCT: grade III-IV acute graft-versus-host disease (GVHD), chronic GVHD requiring systemic immunosuppression, relapse or progression of the hematologic disease, or death from any cause during follow-up.
Measured: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Complications of hematopoietic stem cell transplantation
Complications arising from hematopoietic stem cell transplantation range from early issues such as regimen toxicity and acute GVHD to late effects including chronic GVHD, organ dysfunction, and secondary malignancies.
Measured: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2036 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, First Affiliated Hospital of Zhejiang University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Xinqiao hospital of the third military medical university, The First Affiliated Hospital of Zhengzhou University, Sun Yat-Sen University Cancer Center, Sichuan Provincial People's Hospital, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Xinjiang Medical University, Chinese PLA General Hospital, Peking University Shenzhen Hospital, Peking University Third Hospital, Peking University First Hospital
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349498
- Sponsor's protocol ID
- 2025-z232
- Acronym
- CORE-HCT
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Outcomes and Risk Evaluation Among Recipients of Hematopoietic Stem Cell Transplantation (CORE-HCT): A Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT07349498
- Acronym / sponsor ID
- CORE-HCT / 2025-z232
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, First Affiliated Hospital of Zhejiang University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Xinqiao hospital of the third military medical university, The First Affiliated Hospital of Zhengzhou University, Sun Yat-Sen University Cancer Center, Sichuan Provincial People's Hospital, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Xinjiang Medical University, Chinese PLA General Hospital, Peking University Shenzhen Hospital, Peking University Third Hospital, Peking University First Hospital
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2036 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 16 Jan 2026 (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 is a prospective, multicenter observational study for recipients of hematopoietic stem cell transplantation. Patients who underwent hematopoietic stem cell transplantation at the participating centers will be entrolled in the study. The clinical characteristics, laboratory profiles, management measures, and clinical outcomes such as post-transplant cardiovascular events will be prospectively collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing hematopoietic stem cell transplantation | – | –Patients who undergo allogeneic hematopoietic stem cell transplantation at participating medical center. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who undergo hematopoietic cell transplantation at any of the participating medical centers.
Key inclusion criteria (1 listed)
- Patients who undergo hematopoietic cell transplantation at any of the participating medical centers.
Key exclusion criteria (2 listed)
- Any other conditions that, in the opinion of the investigator, can interfere with the interpretation of data.
- Patient request to withdraw from 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
Major adverse cardiovascular events (MACE)
Time frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Major adverse cardiovascular events (MACE) after hematopoietic stem cell transplantation.
4 secondary outcomes
Cardiovascular events
Time frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Overall survival
Time frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Event-free survival
Time frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Complications of hematopoietic stem cell transplantation
Time frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation and Transplant Complication, run by Peking University People's Hospital at 16 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao Hui Zhang (861088324577, zhangxh@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) (time frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.). 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 16 Jan 2026.