NCT06100328

Brief 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. Various techniques, including general molecular biology analysis and multi-omics analysis, will be used to construct a prognostic model for cardiac tumors.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
51mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Oct 2023Jul 2030

First Submitted

Initial submission to the registry

July 6, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

October 26, 2023

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2030

Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

6.8 years

First QC Date

July 6, 2023

Last Update Submit

July 10, 2024

Conditions

Cardiac Tumor

Keywords

Cardiac tumorDisease characteristicsPrognosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in the incidence of all-cause death

    1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.

  • Change in the incidence of myocardial infarction

    1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.

  • Change in the incidence of coronary revascularization surgery

    1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.

  • Change in the incidence of stroke

    1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.

Study Arms (5)

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

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xi'an Jiantong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Heart Neoplasms

Condition Hierarchy (Ancestors)

Thoracic NeoplasmsNeoplasms by SiteNeoplasmsHeart DiseasesCardiovascular Diseases

Study Officials

  • Guoliang Li

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

  • Yang Yan

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoliang Li

CONTACT

+8613759982523liguoliang_med@163.com

Yang Yan

CONTACT

+8613259882601yangyan3@xjtu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

October 25, 2023

Study Start

October 26, 2023

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations

CN(1)