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NCT Number: NCT06375941

Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars

This study will be a multi-institutional, prospective, observational study of patients with localized primary AS of any site within ISG and RTR centers. Patients will be treated according to clinical practice of the center and according to ISG clinical recommendations on localized AS.

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Key information

Conditions

Angiosarcoma Hemangiosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue Sarcoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas Research Hospital IRCCS, Rozzano, Milano, Italy

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About this study

The management of localized AS remains a clinical challenge and needs to be better defined and standardized, especially with regards to the role of radiation-therapy and systemic treatment. Several questions about the best treatment approach to some clinical presentations remain open and would need to be answered by clinical studies. Unfortunately, the rarity of this histology among sarcomas makes it challenging to carry out clinical studies in all such presentations. Moreover, prognostic factors are lacking and differences in epidemiological, pathological and clinical aspects between primary AS and secondary AS need to be better characterized.

These issues may be addressed with a prospective multi-institutional observational study, through the collection of clinical and pathological data of patients with localized AS.

Involving all reference centres for sarcoma in Italy, the Italian Sarcoma Group (ISG) will be the ideal network for this study, with the collaboration of the Italian Rare Cancer Network (RTR), a 7collaborative network among Italian centres focusing on improving the quality of care of patients with rare tumors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pathological diagnosis of AS;
  • any site of origin;
  • any age;
  • primary, localized, resectable disease.

Exclusion criteria

NA

Treatment and study plan

Observational

Other

Observational

Primary outcomes

  1. Demographic characteristics

    Time frame: At the time of enrollment

    Demographic data

  2. General characteristics

    Time frame: At the time of enrollment

    Comorbidities

  3. Cancer data

    Time frame: At the time of enrollment

    Previous cancer data

  4. Origin of Tumor

    Time frame: At the time of enrollment

    Site of origin

  5. Tumor characteristics

    Time frame: At the time of enrollment

    Multifocality

  6. Tumor size

    Time frame: At the time of enrollment

    Size

  7. Tumor aspects

    Time frame: 10 years

    Morphological aspects

  8. Pathological characteristics

    Time frame: 10 years

    Proliferative index

  9. Tumor phenotype

    Time frame: 10 years

    Tumor cell phenotype

  10. Molecular characteristics

    Time frame: 10 years

    Molecular aspects

Study contacts

Contact information is provided by the study sponsor or research team.

Gianluca Ignazzi

CONTACT

[email protected]

+393335359192

Viviana Appolloni

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Italian Sarcoma Group

Network

Registry information

Acronym: ProStars

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Apr 19, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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