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Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars

Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06375941
Acronym
ProStars
Enrollment
250
Registered
2024-04-19
Start date
2024-03-29
Completion date
2034-04-01
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angiosarcoma

Brief summary

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.

Detailed description

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.

Interventions

OTHERObservational

Observational

Sponsors

Italian Sarcoma Group
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

NA

Design outcomes

Primary

MeasureTime frameDescription
Demographic characteristicsAt the time of enrollmentDemographic data
General characteristicsAt the time of enrollmentComorbidities
Cancer dataAt the time of enrollmentPrevious cancer data
Origin of TumorAt the time of enrollmentSite of origin
Tumor characteristicsAt the time of enrollmentMultifocality
Tumor sizeAt the time of enrollmentSize
Tumor aspects10 yearsMorphological aspects
Pathological characteristics10 yearsProliferative index
Tumor phenotype10 yearsTumor cell phenotype
Molecular characteristics10 yearsMolecular aspects

Countries

Italy

Contacts

Primary ContactGianluca Ignazzi
gianluca.ignazzi@italiansarcomagroup.org+393335359192
Backup ContactViviana Appolloni
viviana.appolloni@italiansarcomagroup.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026