Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars

Angiosarcoma Clinical Trial

— ProStars  

Official title:

Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06375941
• Other study ID #: ProStars
• Status: Recruiting
• Start date: March 29, 2024
• Est. completion date: April 1, 2034

Study information

• Verified date: April 2024
• Source: Italian Sarcoma Group
• Contact: Gianluca Ignazzi
• Phone: +393335359192
• Email: gianluca.ignazzi[@]italiansarcomagroup.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 1, 2034
• Est. primary completion date: April 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Angiosarcoma

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
Italy	IRCCS Istituto Nazionale Tumori - Milano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Italian Sarcoma Group

Country where clinical trial is conducted

Italy, 

Outcome

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

External Links

•   Italian Sarcoma Group website