NCT06375941

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
96mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Mar 2024Apr 2034

Study Start

First participant enrolled

March 29, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2034

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

5 years

First QC Date

April 5, 2024

Last Update Submit

November 17, 2025

Conditions

Outcome Measures

Primary Outcomes (10)

  • Demographic characteristics

    Demographic data

    At the time of enrollment

  • General characteristics

    Comorbidities

    At the time of enrollment

  • Cancer data

    Previous cancer data

    At the time of enrollment

  • Origin of Tumor

    Site of origin

    At the time of enrollment

  • Tumor characteristics

    Multifocality

    At the time of enrollment

  • Tumor size

    Size

    At the time of enrollment

  • Tumor aspects

    Morphological aspects

    10 years

  • Pathological characteristics

    Proliferative index

    10 years

  • Tumor phenotype

    Tumor cell phenotype

    10 years

  • Molecular characteristics

    Molecular aspects

    10 years

Study Arms (1)

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

Interventions

Observational

Pathological diagnosis of AS, any site of origin, any age, primary, localized, resectable disease.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Istituto Clinico Humanitas Research Hospital IRCCS

Rozzano, Milano, 20089, Italy

NOT YET RECRUITING

Centro Riferimento Oncologico CRO

Aviano, Pordenone, 33081, Italy

RECRUITING

AOU San Luigi Gonzaga

Orbassano, Torino, 10043, Italy

RECRUITING

Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.

Bari, 70124, Italy

NOT YET RECRUITING

Istituto Ortopedico Rizzoli IOR

Bologna, 40136, Italy

RECRUITING

Policlinico "Sant'Orsola-Malpighi"

Bologna, 40138, Italy

RECRUITING

A.O.U. Careggi

Florence, 50134, Italy

NOT YET RECRUITING

Ospedale Policlinico san Martino IRCCS

Genova, 16132, Italy

RECRUITING

IRCCS Istituto Nazionale Tumori - Milano

Milan, 20133, Italy

RECRUITING

IRCCS Istituto Europeo di Oncologia

Milan, 20141, Italy

NOT YET RECRUITING

Fondazione Irccs San Gerardo Dei Tintori

Monza, 20900, Italy

NOT YET RECRUITING

Istituto Nazionale Tumori_Fondazione "G.Pascale"

Napoli, 80131, Italy

RECRUITING

IOV Istituto Oncologico Veneto IRCCS

Padua, 35128, Italy

RECRUITING

Policlinico "Paolo Giaccone"

Palermo, 90127, Italy

RECRUITING

Nuovo Ospedale di Prato - S. Stefano

Prato, 59100, Italy

RECRUITING

Fondazione Policlinico Campus Biomedico

Roma, 00128, Italy

RECRUITING

IRCCS Istituti Fisioterapici Ospitalieri

Roma, 00144, Italy

NOT YET RECRUITING

ASL Ospedale San Giovanni Bosco

Torino, 10154, Italy

RECRUITING

Ospedale di Trento

Trento, 38123, Italy

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Hemangiosarcoma

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

SarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Elena Palassini

    IRCCS Istituto nazionale Tumori - Milano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 19, 2024

Study Start

March 29, 2024

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2034

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations