Clinical trial NCT06375941: Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars
Official title: Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Angiosarcoma
Lead sponsor: Italian Sarcoma Group
Sponsor class: NETWORK
First posted: 2024-04-19
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * pathological diagnosis of AS;
* any site of origin;
* any age;
* primary, localized, resectable disease.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria: NA

Primary outcomes:
measure: Demographic characteristics
timeFrame: At the time of enrollment
measure: General characteristics
timeFrame: At the time of enrollment
measure: Cancer data
timeFrame: At the time of enrollment
measure: Origin of Tumor
timeFrame: At the time of enrollment
measure: Tumor characteristics
timeFrame: At the time of enrollment
measure: Tumor size
timeFrame: At the time of enrollment
measure: Tumor aspects
timeFrame: 10 years
measure: Pathological characteristics
timeFrame: 10 years
measure: Tumor phenotype
timeFrame: 10 years
measure: Molecular characteristics
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro Riferimento Oncologico CRO
state: Pordenone
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga
state: Torino
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli IOR
city: Bologna
country: Italy
facility: Policlinico "Sant'Orsola-Malpighi"
city: Milano
country: Italy
facility: IRCCS Istituto Nazionale Tumori - Milano
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori_Fondazione "G.Pascale"
city: Padova
country: Italy
facility: IOV Istituto Oncologico Veneto IRCCS
city: Palermo
country: Italy
facility: Policlinico "Paolo Giaccone"
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato - S. Stefano
city: Roma
country: Italy
facility: Fondazione Policlinico Campus Biomedico
city: Torino
country: Italy
facility: ASL Ospedale San Giovanni Bosco
Study officials:
affiliation: IRCCS Istituto nazionale Tumori - Milano
name: Elena Palassini
role: PRINCIPAL_INVESTIGATOR
References: