The Observational EURACAN Prospective Clinical Registry Dedicated to Epithelioid Hemangioendothelioma: the Protocol of an International and Collaborative Effort on an Ultra-rare Entity

Status: Recruiting
Location: See all (21) locations...
Study Type: Observational
SUMMARY

Epithelioid hemangioendothelioma (EHE) is an ultra-rare sarcoma, marked by distinctive molecular and pathological features and with a variable clinical behavior. Its natural history is still partially understood, reliable prognostic and predictive factors are lacking and many questions are still open on the optimal management. In the context of EURACAN, a prospective registry specifically dedicated to EHE was developed and launched with the aim of providing, through high-quality prospective data collection, a better understanding of this disease. The study design is a registry-based cohort study including only new cases of patients with a pathological and molecularly confirmed diagnosis of EHE. The objectives are to improve the understanding of EHE natural history, validate and identify new prognostic and predictive factors, clarify the activity and efficacy of currently available treatment options, describe treatment pattern. It is an hospital-based registry established in centres with expertise in EHE including adult patients with a new pathological and molecularly confirmed diagnosis of EHE starting from the 1st December 2023. The characteristics of each patient in the facility who meets the above-mentioned inclusion criteria will be collected prospectively and longitudinally with follow-up at cancer progression and / or cancer relapse or patient death. The data analyses will include descriptive statistics and analytical analyses. Multivariable Cox's proportional hazards model and Hazard ratios (HR) for all-cause or cause-specific mortality will be used to determine independent predictors of overall survival, recurrence and progression. The registry has been joined by 21 sarcoma reference centers across EU and UK, covering 10 countries. Patients' recruitment started in December 2023. The estimated completion date is December 2033 upon agreement on the achievement of all the registry objectives. The already established collaboration and participation of EHE patient's associations involved in the project will help in promoting the registry and fostering accrual. This registry has been developed with the support of EHE Rare Cancer Charity UK, STATER (Grant Agreement number: 947604, HP-PJ-2019) and EURACAN 2022 (Grant Agreement number: 101085486, EU4H-2022-ERN-IBA) European Health and Digital Executive Agency (HaDEA)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• New patients managed by the contributing centers with a pathological EHE diagnosis performed or verified by an expert sarcoma pathologist starting from 1 December 2023 onwards and to be performed within 6 months from the registration

• Molecular confirmation of the diagnosis (WWTR1-CAMTA1 or YAP1-TFE3)

• Adult patients (aged ≥ 18 years)

Locations
Other Locations
Austria
University Hospital Graz
RECRUITING
Graz
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
France
Léon Bérard Center
RECRUITING
Lyon
Germany
Essen University Hospital
RECRUITING
Essen
Italy
Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Azienda Ospedaliero Universitaria Careggi
RECRUITING
Careggi
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Azienda Ospedaliera Universitaria San Luigi Gonzaga
RECRUITING
Orbassano
Istituto Oncologico Veneto
RECRUITING
Padua
Policlinico Universitario P. Giaccone
RECRUITING
Palermo
Nuovo Ospedale di Prato S.Stefano
RECRUITING
Prato
Istituto Nazionale dei Tumori Regina Elena
RECRUITING
Roma
Università Campus Bio-Medico
RECRUITING
Roma
IRCCS Istituto Clinica Humanitas
RECRUITING
Rozzano
Norway
Oslo University hospital Ullevål
WITHDRAWN
Oslo
Poland
Maria Skłodowska-Curie Institute of Oncology
RECRUITING
Warsaw
Spain
Vall d'Hebron University Hospital
RECRUITING
Barcelona
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Karolinska University Hospital
RECRUITING
Stockholm
United Kingdom
The Royal Marsden Hospital
RECRUITING
London
Contact Information
Primary
Annalisa Trama, MD
annalisa.trama@istitutotumori.mi.it
02 2390 3535
Backup
Melissa Gil Sanjines
melissa.gilsanjines@istitutotumori.mi.it
02 2390 3564
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2033-12-01
Participants
Target number of participants: 100
Treatments
unifocal disease
Primary, localized, single lesion
Loco-regional disease
multifocal single-organ involvement
Systemic metastases
multi-organ involvement and/or loco-regional lymph-node involvement
Sponsors
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov