Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars

Recruiting

• Conditions: Angiosarcoma
• Interventions: Other: Observational

• Registration Number: NCT06375941
• Lead Sponsor: Italian Sarcoma Group

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.

Study Timeline

• Study Start: 2024-03-29
• Status Verified: 2024-04
• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17
• Primary Completion: 2029-04-01
• Study Completion: 2034-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

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Exclusion Criteria

NA

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pathological diagnosis of AS, any site of origin, any age, primary, localized, resectable disease.	Observational	* pathological diagnosis of AS; * any site of origin; * any age; * primary, localized, resectable disease.

Primary Outcome Measures

Name	Time	Method
General characteristics	At the time of enrollment	Comorbidities
Tumor size	At the time of enrollment	Size
Tumor characteristics	At the time of enrollment	Multifocality
Tumor aspects	10 years	Morphological aspects
Pathological characteristics	10 years	Proliferative index
Demographic characteristics	At the time of enrollment	Demographic data
Cancer data	At the time of enrollment	Previous cancer data
Tumor phenotype	10 years	Tumor cell phenotype
Origin of Tumor	At the time of enrollment	Site of origin
Molecular characteristics	10 years	Molecular aspects

Trial Locations

Locations (4)

Fondazione Policlinico Campus Biomedico; 🇮🇹 Roma, Italy

IRCCS Istituto Nazionale Tumori - Milano; 🇮🇹 Milano, Italy

IOV Istituto Oncologico Veneto IRCCS; 🇮🇹 Padova, Italy

Nuovo Ospedale di Prato - S. Stefano; 🇮🇹 Prato, Italy