Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE) (UNIQUE)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Tumor

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Guoliang Li; Phone Number: +8613759982523; Email: liguoliang_med@163.com
• Study Contact Backup: Name: Yang Yan; Phone Number: +8613259882601; Email: yangyan3@xjtu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xi'an Jiantong University
      • Contact: Guoliang Li; Phone Number: 008613759982523; Email: liguoliang_med@163.com
      • Contact: Yang Yan; Phone Number: +862985323865; Email: yangyan3@xjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the incidence of all-cause death	All-cause death diagnosed by clinical doctors will be assessed from the medical records	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	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	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	1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Guoliang Li, First Affiliated Hospital Xi'an Jiaotong University; Principal Investigator: Yang Yan, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Prognosis; Cardiac tumor; Disease characteristics
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Neoplasms; Neoplasms by Site; Thoracic Neoplasms; Heart Neoplasms
• Other Study ID Numbers: XJTU1AF2023LSK-284

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No