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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Italian Sarcoma Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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