Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars (ProStars)

November 17, 2025 updated by: Italian Sarcoma Group
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Not yet recruiting
        • Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
        • Contact:
          • Sabino Strippoli, MD
      • Bologna, Italy, 40136
        • Recruiting
        • Istituto Ortopedico Rizzoli IOR
        • Contact:
          • Toni Ibrahim, MD
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico "Sant'Orsola-Malpighi"
        • Contact:
          • Maria Abbondanza Pantaleo, Prof.
      • Florence, Italy, 50134
        • Not yet recruiting
        • A.O.U. Careggi
        • Contact:
          • Lorenzo Livi, MD
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale Policlinico San Martino IRCCS
        • Contact:
          • Danila Comandini, MD
      • Milan, Italy, 20133
        • Recruiting
        • IRCCS Istituto Nazionale Tumori - Milano
        • Contact:
          • Palassini Elena
      • Milan, Italy, 20141
        • Not yet recruiting
        • IRCCS Istituto Europeo di Oncologia
        • Contact:
          • Elisabetta Pennacchioli, MD
      • Monza, Italy, 20900
        • Not yet recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
        • Contact:
          • Marinella Mastore, MD
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori_Fondazione "G.Pascale"
        • Contact:
          • Lucia Cannella, MD
      • Padua, Italy, 35128
        • Recruiting
        • IOV Istituto Oncologico Veneto IRCCS
        • Contact:
          • Antonella Brunello
      • Palermo, Italy, 90127
        • Recruiting
        • Policlinico "Paolo Giaccone"
        • Contact:
          • Giuseppe Badalamenti, Prof.
      • Prato, Italy, 59100
        • Recruiting
        • Nuovo Ospedale di Prato - S. Stefano
        • Contact:
          • Giacomo Giulio Baldi
      • Roma, Italy, 00128
        • Recruiting
        • Fondazione Policlinico Campus BioMedico
        • Contact:
          • Bruno Vincenzi, prof
      • Roma, Italy, 00144
        • Not yet recruiting
        • IRCCS Istituti Fisioterapici Ospitalieri
        • Contact:
          • Virginia Ferraresi, MD
      • Torino, Italy, 10154
        • Recruiting
        • ASL Ospedale San Giovanni Bosco
        • Contact:
          • Antonella Boglione, MD
      • Trento, Italy, 38123
        • Not yet recruiting
        • Ospedale di Trento
        • Contact:
          • Marco Cianchetti, MD
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Not yet recruiting
        • Istituto Clinico Humanitas Research Hospital IRCCS
        • Contact:
          • Alexia Bertuzzi, MD
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Recruiting
        • Centro Riferimento Oncologico CRO
        • Contact:
          • Federico Navarria, MD
    • Torino
      • Orbassano, Torino, Italy, 10043
        • Recruiting
        • Aou San Luigi Gonzaga
        • Contact:
          • Lorenzo D'Ambrosio, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria: NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pathological diagnosis of AS, any site of origin, any age, primary, localized, resectable disease.
  • pathological diagnosis of AS;
  • any site of origin;
  • any age;
  • primary, localized, resectable disease.
Other: Observational
Observational

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Sarcoma Group

Investigators

  • Principal Investigator: Elena Palassini, IRCCS Istituto Nazionale Tumori - Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2024

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2034

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProStars

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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