AngiosarcomaProStarsNCT06375941
Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars
An observational study of Angiosarcoma, run by Italian Sarcoma Group at 19 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angiosarcoma
- What is being tested?
- Observational
- How many people
- 250 participants
- Where
- 19 sitesItaly
- Study dates
- 29 Mar 2024to 1 Apr 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * pathological diagnosis of AS; * any site of origin; * any age; * primary, localized, resectable disease.
Who may be able to join
- pathological diagnosis of AS;
- any site of origin;
- any age;
- primary, localized, resectable disease.
Who cannot join
None listed.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Viviana Appolloni contact
19 sites in 1 country
Italy19 sites, 19 recruiting
- Recruiting
Centro Riferimento Oncologico CRO
Aviano, Pordenone, 33081
Federico Navarria, MD
- Not yet recruiting
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
Bari, 70124
Sabino Strippoli, MD
- Recruiting
Istituto Ortopedico Rizzoli IOR
Bologna, 40136
Toni Ibrahim, MD
- Recruiting
Policlinico "Sant'Orsola-Malpighi"
Bologna, 40138
Maria Abbondanza Pantaleo, Prof.
- Not yet recruiting
A.O.U. Careggi
Florence, 50134
Lorenzo Livi, MD
- Recruiting
Ospedale Policlinico san Martino IRCCS
Genova, 16132
Danila Comandini, MD
- Recruiting
IRCCS Istituto Nazionale Tumori - Milano
Milan, 20133
Palassini Elena
- Not yet recruiting
IRCCS Istituto Europeo di Oncologia
Milan, 20141
Elisabetta Pennacchioli, MD
- Not yet recruiting
Fondazione Irccs San Gerardo Dei Tintori
Monza, 20900
Marinella Mastore, MD
- Recruiting
Istituto Nazionale Tumori_Fondazione "G.Pascale"
Naples, 80131
Lucia Cannella, MD
- Recruiting
AOU San Luigi Gonzaga
Orbassano, Torino, 10043
Lorenzo D'Ambrosio, MD
- Recruiting
IOV Istituto Oncologico Veneto IRCCS
Padova, 35128
Antonella Brunello
- Recruiting
Policlinico "Paolo Giaccone"
Palermo, 90127
Giuseppe Badalamenti, Prof.
- Recruiting
Nuovo Ospedale di Prato - S. Stefano
Prato, 59100
Giacomo Giulio Baldi
- Recruiting
Fondazione Policlinico Campus Biomedico
Roma, 00128
Bruno Vincenzi, prof
- Not yet recruiting
IRCCS Istituti Fisioterapici Ospitalieri
Roma, 00144
Virginia Ferraresi, MD
- Not yet recruiting
Istituto Clinico Humanitas Research Hospital IRCCS
Rozzano, Milano, 20089
Alexia Bertuzzi, MD
- Recruiting
ASL Ospedale San Giovanni Bosco
Torino, 10154
Antonella Boglione, MD
- Not yet recruiting
Ospedale di Trento
Trento, 38123
Marco Cianchetti, MD
About this study
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.
Read the 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.
- Conditions
- Angiosarcoma
- Being tested
- Observational
- Medical subject headings
- Hemangiosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic characteristics
Demographic data
Measured: At the time of enrollment
General characteristics
Comorbidities
Measured: At the time of enrollment
Cancer data
Previous cancer data
Measured: At the time of enrollment
Origin of Tumor
Site of origin
Measured: At the time of enrollment
Tumor characteristics
Multifocality
Measured: At the time of enrollment
Tumor size
Size
Measured: At the time of enrollment
Tumor aspects
Morphological aspects
Measured: 10 years
Pathological characteristics
Proliferative index
Measured: 10 years
Tumor phenotype
Tumor cell phenotype
Measured: 10 years
Molecular characteristics
Molecular aspects
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start29 Mar 2024
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngiosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Italian Sarcoma Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Elena Palassini, Principal investigator, IRCCS Istituto nazionale Tumori - Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375941
- Sponsor's protocol ID
- ProStars
- Acronym
- ProStars
- Status last verified
- Nov 2025
- First submitted
- 5 Apr 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars
- ClinicalTrials.gov ID
- NCT06375941
- Acronym / sponsor ID
- ProStars / ProStars
- Conditions
- Angiosarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Italian Sarcoma GroupResearch network
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2034 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pathological diagnosis of AS, any site of origin, any age, primary, localized, resectable disease. | – | Other: Observational* pathological diagnosis of AS; * any site of origin; * any age; * primary, localized, resectable disease. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * pathological diagnosis of AS; * any site of origin; * any age; * primary, localized, resectable disease.
Key inclusion criteria (4 listed)
- pathological diagnosis of AS;
- any site of origin;
- any age;
- primary, localized, resectable disease.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | Pathological diagnosis of AS, any site of origin, any age, primary, localized, resectable disease. |
Primary outcome
Demographic characteristics
Time frame: At the time of enrollment
Demographic data
General characteristics
Time frame: At the time of enrollment
Comorbidities
Cancer data
Time frame: At the time of enrollment
Previous cancer data
Origin of Tumor
Time frame: At the time of enrollment
Site of origin
Tumor characteristics
Time frame: At the time of enrollment
Multifocality
Tumor size
Time frame: At the time of enrollment
Size
Tumor aspects
Time frame: 10 years
Morphological aspects
Pathological characteristics
Time frame: 10 years
Proliferative index
Tumor phenotype
Time frame: 10 years
Tumor cell phenotype
Molecular characteristics
Time frame: 10 years
Molecular aspects
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Italian Sarcoma Group websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Viviana Appolloni contact
Elena Palassini principal investigator
IRCCS Istituto nazionale Tumori - Milano
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angiosarcoma, run by Italian Sarcoma Group at 19 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluca Ignazzi (+393335359192, gianluca.ignazzi@italiansarcomagroup.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic characteristics (time frame: At the time of enrollment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.