NCT06715579

Brief Summary

Primary cardiac angiosarcomas (PCA) are highly aggressive malignant heart tumors arising from the endothelial cells (ECs) lining the blood vessels of the heart and account for approximately 25%-30% of all primary cardiac malignancies. It is considered to be the most fatal and aggressive primary cardiac malignancy. This international registry aims to establish a large multicenter database of patients with cardiac angiosarcoma. Our objectives are:

  1. 1.Collect clinical data, including demographics, medical history, treatments, and outcomes, to build a comprehensive database.
  2. 2.Analyze data to evaluate and identify genetic, environmental, or lifestyle risk factors for cardiac angiosarcoma.
  3. 3.Evaluate the effectiveness of various treatments (surgery, chemotherapy, immunotherapy, radiation) to inform best practices.
  4. 4.Develop evidence-based guidelines and recommendations for prevention, diagnosis, treatment, and management based on registry data.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
110mo left

Started May 2025

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 Progress10%
May 2025May 2035

First Submitted

Initial submission to the registry

November 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2035

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

10 years

First QC Date

November 28, 2024

Last Update Submit

February 15, 2026

Conditions

Keywords

Cardiac AngiosarcomaAngiosarcomaHemangiosarcomaEpithelioid HemangiosarcomaPrimary Cardiac Sarcoma

Outcome Measures

Primary Outcomes (1)

  • 6-month overall survival

    6 months

Secondary Outcomes (8)

  • 1-year overall survival

    1 year

  • 6-month progression free survival

    6 months

  • 1-year progression free survival

    1 year

  • 3-year progression free survival

    3 years

  • 6-month event-free survival

    6 months

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients diagnosed with Cardiac Angiosarcoma

You may qualify if:

  • Histological Confirmation: A confirmed diagnosis of cardiac angiosarcoma through histopathological examination, including subtypes such as hemangiosarcoma and epithelioid hemangiosarcoma.
  • Diagnosis Timing: Eligible patients must have been diagnosed between January 2015 and January 2035.
  • Geographical Representation: Participants should be from diverse geographical locations to ensure a comprehensive understanding of the disease across different populations.
  • Treatment Status: Patients who have received any treatment (surgery, chemotherapy, immunotherapy or radiation) for cardiac angiosarcoma may be included to evaluate treatment outcomes.
  • Informed Consent: For prospective patients, informed consent must be obtained before they are included in the registry.
  • Clinical Data Availability: Relevant clinical data, including demographics, tumor characteristics (size, location), treatment regimens, and outcomes, must be available for analysis.
  • Follow-Up Willingness: Participants should be willing to undergo follow-up assessments as part of the registry's data collection efforts.

You may not qualify if:

  • Patients who decline to provide informed consent.
  • Cases where cardiac involvement is secondary to another primary malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeolyan Hematology and Oncology Center

Yerevan, 0014, Armenia

RECRUITING

MeSH Terms

Conditions

Hemangiosarcoma

Condition Hierarchy (Ancestors)

SarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular Tissue

Study Officials

  • Shushan Hovsepyan, MD

    Immune Oncology Research Institute, Yerevan, Armenia

    PRINCIPAL INVESTIGATOR
  • Amalya Sargsyan, MD

    Immune Oncology Research Institute, Yerevan, Armenia

    STUDY CHAIR
  • Ruzanna Papyan, MD

    Immune Oncology Research Institute, Yerevan, Armenia

    STUDY DIRECTOR

Central Study Contacts

Aharon Tsaturyan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 4, 2024

Study Start

May 1, 2025

Primary Completion (Estimated)

May 1, 2035

Study Completion (Estimated)

May 1, 2035

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations