Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational.
- Who it may be relevant to
- Registry conditions: Angiosarcoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Observational
Observational
Primary outcome measures
- Demographic characteristics [Time frame: At the time of enrollment]
- General characteristics [Time frame: At the time of enrollment]
- Cancer data [Time frame: At the time of enrollment]
- Origin of Tumor [Time frame: At the time of enrollment]
- Tumor characteristics [Time frame: At the time of enrollment]
- Tumor size [Time frame: At the time of enrollment]
- Tumor aspects [Time frame: 10 years]
- Pathological characteristics [Time frame: 10 years]
- Tumor phenotype [Time frame: 10 years]
- Molecular characteristics [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- pathological diagnosis of AS;
- any site of origin;
- any age;
- primary, localized, resectable disease.
Exclusion Criteria: NA
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 19 centers
- Istituto Clinico Humanitas Research Hospital IRCCS — Rozzano
- Centro Riferimento Oncologico CRO — Aviano
- AOU San Luigi Gonzaga — Orbassano
- Istituto Tumori "Giovanni Paolo II" I.R.C.C.S. — Bari
- Istituto Ortopedico Rizzoli IOR — Bologna
- Policlinico "Sant'Orsola-Malpighi" — Bologna
- A.O.U. Careggi — Florence
- Ospedale Policlinico san Martino IRCCS — Genova
- … and 11 more centers
Identifiers
NCT: NCT06375941 · ProStars