Cardiac TumorUNIQUENCT06100328
Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE)
An observational study of Cardiac Tumor, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study aims to retrospectively and prospectively collect clinical and biological specimen data from patients with cardiac tumors who meet the inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Cardiac Tumor
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2023to 31 Jul 2030
- 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 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients must meet at least one of the following diagnostic criteria for cardiac neoplasms: 1. Cardiac myxoma group; 2. Cardiac fibroma group; 3. Cardiac lipoma group; 4. Cardiac hemangioma group; 5. Cardiac undifferentiated sarcoma; 6. Cardiac angiosarcoma group; 7. Cardiac rhabdomyosarcoma group; 8. Cardiac lymphoma group; 9. Cardiac metastasis group; 10. Other cardiac tumors group.
Who may be able to join
- Patients who are regularly visited and followed up in the corresponding cardiovascular center.
- All patients must meet at least one of the following diagnostic criteria for cardiac neoplasms: 1. Cardiac myxoma group; 2. Cardiac fibroma group; 3. Cardiac lipoma group; 4. Cardiac hemangioma group; 5. Cardiac undifferentiated sarcoma; 6. Cardiac angiosarcoma group; 7. Cardiac rhabdomyosarcoma group; 8. Cardiac lymphoma group; 9. Cardiac metastasis group; 10. Other cardiac tumors group.
Who cannot join
- Age <3 years or >80 years old.
- Pregnant and lactating women.
- The patient declined to provide informed consent to participate in the study.
- None of the above was met, but the patient was temporarily unable to sign the informed consent form due to coma and other reasons, and no legal representative signed it instead. Depending on the patient's condition, the patient may not be able to regain consciousness and sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiantong University
Xi'an, Shaanxi, 710061
Guoliang Li, 008613759982523, liguoliang_med@163.com
Yang Yan, +862985323865, yangyan3@xjtu.edu.cn
About this study
Official title: Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Cohort Study
This study aims to retrospectively and prospectively collect clinical and biological specimen data from patients with cardiac tumors who meet the inclusion and exclusion criteria. Various techniques, including general molecular biology analysis and multi-omics analysis, will be used to construct a prognostic model for cardiac tumors.
Read the detailed description
This study aims to construct a retrospective-prospective long-term follow-up cohort and management system for cardiac tumors through a multi-centre collaborative network. The duration of the study will be divided into retrospective and prospective components. The retrospective study will collect cases of cardiac tumors from 2003-2022; the prospective study is expected to collect cases of cardiac tumors from 2022-2030. The study is expected to assess the disease characteristics, progression patterns, clinical features, natural course and long-term prognosis of cardiac tumors.
- Conditions
- Cardiac Tumor
- Keywords
- Cardiac tumor, Disease characteristics, Prognosis
- Medical subject headings
- Heart 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 |
|---|---|---|
| Cardiac myxoma group | patients who are diagnosed as cardiac myxoma | |
| Cardiac fibroma group | patients who are diagnosed as cardiac fibroma | |
| Cardiac lipoma group | patients who are diagnosed as cardiac lipoma | |
| Cardiac hemangioma group | patients who are diagnosed as cardiac hemangioma | |
| Cardiac malignant tumor group | patients who are diagnosed as cardiac malignant tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the incidence of MACCE
MACCE (major adverse cardiac and cerebrovascular events) including all-cause death, myocardial infarction, coronary revascularization surgery and stroke. The MACCE will be assessed from the medical records.
Measured: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
Secondary outcomes (4)
Change in the incidence of all-cause death
All-cause death diagnosed by clinical doctors will be assessed from the medical records
Measured: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
Change in the incidence of myocardial infarction
Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records
Measured: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
Change in the incidence of coronary revascularization surgery
Coronary revascularization surgery completed by clinical doctors will be assessed from the medica records
Measured: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
Change in the incidence of stroke
Stroke diagnosed by clinical doctors will be assessed from the medical records
Measured: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start26 Oct 2023
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac TumorStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoliang Li, Principal investigator, First Affiliated Hospital Xi'an Jiaotong UniversityYang Yan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100328
- Sponsor's protocol ID
- XJTU1AF2023LSK-284
- Acronym
- UNIQUE
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT06100328
- Acronym / sponsor ID
- UNIQUE / XJTU1AF2023LSK-284
- Conditions
- Cardiac Tumor
- Keywords
- Cardiac tumor, Disease characteristics, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 25 Oct 2023 (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 retrospectively and prospectively collect clinical and biological specimen data from patients with cardiac tumors who meet the inclusion and exclusion criteria. Various techniques, including general molecular biology analysis and multi-omics analysis, will be used to construct a prognostic model for cardiac tumors.
Detailed description
This study aims to construct a retrospective-prospective long-term follow-up cohort and management system for cardiac tumors through a multi-centre collaborative network. The duration of the study will be divided into retrospective and prospective components. The retrospective study will collect cases of cardiac tumors from 2003-2022; the prospective study is expected to collect cases of cardiac tumors from 2022-2030. The study is expected to assess the disease characteristics, progression patterns, clinical features, natural course and long-term prognosis of cardiac tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cardiac myxoma group | – | –patients who are diagnosed as cardiac myxoma |
| Cardiac fibroma group | – | –patients who are diagnosed as cardiac fibroma |
| Cardiac lipoma group | – | –patients who are diagnosed as cardiac lipoma |
| Cardiac hemangioma group | – | –patients who are diagnosed as cardiac hemangioma |
| Cardiac malignant tumor group | – | –patients who are diagnosed as cardiac malignant tumor |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients must meet at least one of the following diagnostic criteria for cardiac neoplasms: 1. Cardiac myxoma group; 2. Cardiac fibroma group; 3. Cardiac lipoma group; 4. Cardiac hemangioma group; 5. Cardiac undifferentiated sarcoma; 6. Cardiac angiosarcoma group; 7. Cardiac rhabdomyosarcoma group; 8. Cardiac lymphoma group; 9. Cardiac metastasis group; 10. Other cardiac tumors group.
Key inclusion criteria (2 listed)
- Patients who are regularly visited and followed up in the corresponding cardiovascular center.
- All patients must meet at least one of the following diagnostic criteria for cardiac neoplasms: 1. Cardiac myxoma group; 2. Cardiac fibroma group; 3. Cardiac lipoma group; 4. Cardiac hemangioma group; 5. Cardiac undifferentiated sarcoma; 6. Cardiac angiosarcoma group; 7. Cardiac rhabdomyosarcoma group; 8. Cardiac lymphoma group; 9. Cardiac metastasis group; 10. Other cardiac tumors group.
Key exclusion criteria (4 listed)
- Age <3 years or >80 years old.
- Pregnant and lactating women.
- The patient declined to provide informed consent to participate in the study.
- None of the above was met, but the patient was temporarily unable to sign the informed consent form due to coma and other reasons, and no legal representative signed it instead. Depending on the patient's condition, the patient may not be able to regain consciousness and sign the informed consent form.
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
Change in the incidence of MACCE
Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
MACCE (major adverse cardiac and cerebrovascular events) including all-cause death, myocardial infarction, coronary revascularization surgery and stroke. The MACCE will be assessed from the medical records.
4 secondary outcomes
Change in the incidence of all-cause death
Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
Change in the incidence of myocardial infarction
Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
Change in the incidence of coronary revascularization surgery
Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
Change in the incidence of stroke
Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
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 12 Jul 2024.
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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.
Guoliang Li principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Yang Yan principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Tumor, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site 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 2 inclusion and 4 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 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Guoliang Li (+8613759982523, liguoliang_med@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the incidence of MACCE (time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.). 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 12 Jul 2024.