The observational EURACAN prospective clinical registry dedicated to epithelioid hemangioendothelioma: The protocol of an international and collaborative effort on an ultra-rare entity.
<h4>Introduction</h4>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...
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2024-01-01
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| Online Access: | https://doi.org/10.1371/journal.pone.0308387 |
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| author | Anna Maria Frezza Hugh Leonard Ninna Aggerholm-Pedersen Giuseppe Badalamenti Paolo Baili Giacomo G Baldi Sebastian Bauer Serena Bazzurri Irene Benzonelli Alexia Bertuzzi Jean-Yves Blay Giuseppe Bianchi Simone Bonfarnuzzo Christophe Bouvier Kyetil Boye Javier Martin Broto Antonella Brunello Domenico Campanacci Paolo G Casali Carlo Cicala Elisa Crotti Lorenzo D'Ambrosio Angelo Paolo Dei Tos Nils Dieckmann Armelle Dufresne Stephanie Elston Virginia Ferraresi Stefano Gabellini Claudia Giani Vincenzo Giannusa Melissa Gil Sanjines Teresa Grassani Alessandro Gronchi Paolo Lasalvia Stefan Lindskog Nadia Hindi Matilde Ingrosso Andrei Ivanescu Robin Jones Iwona Lugowska Julia Ketzer Anna Mariuk-Jarema Alessandro Mazzocca Laura Monteleone Carlo Morosi Andrea Napolitano Francesca Nardozza Elisabetta Neri Maria Nilsson Andri Papakonstantinou Sandro Pasquali Marta Sbaraglia Federico Scolari Joanna Szkandera Claudia Valverde Bruno Vincenzi Salvatore Vizzaccaro Federica Zuccheri Silvia Stacchiotti Annalisa Trama |
| author_facet | Anna Maria Frezza Hugh Leonard Ninna Aggerholm-Pedersen Giuseppe Badalamenti Paolo Baili Giacomo G Baldi Sebastian Bauer Serena Bazzurri Irene Benzonelli Alexia Bertuzzi Jean-Yves Blay Giuseppe Bianchi Simone Bonfarnuzzo Christophe Bouvier Kyetil Boye Javier Martin Broto Antonella Brunello Domenico Campanacci Paolo G Casali Carlo Cicala Elisa Crotti Lorenzo D'Ambrosio Angelo Paolo Dei Tos Nils Dieckmann Armelle Dufresne Stephanie Elston Virginia Ferraresi Stefano Gabellini Claudia Giani Vincenzo Giannusa Melissa Gil Sanjines Teresa Grassani Alessandro Gronchi Paolo Lasalvia Stefan Lindskog Nadia Hindi Matilde Ingrosso Andrei Ivanescu Robin Jones Iwona Lugowska Julia Ketzer Anna Mariuk-Jarema Alessandro Mazzocca Laura Monteleone Carlo Morosi Andrea Napolitano Francesca Nardozza Elisabetta Neri Maria Nilsson Andri Papakonstantinou Sandro Pasquali Marta Sbaraglia Federico Scolari Joanna Szkandera Claudia Valverde Bruno Vincenzi Salvatore Vizzaccaro Federica Zuccheri Silvia Stacchiotti Annalisa Trama |
| author_sort | Anna Maria Frezza |
| collection | DOAJ |
| description | <h4>Introduction</h4>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.<h4>Study design</h4>Registry-based cohort study including only new cases of patients with a pathological and molecularly confirmed diagnosis of EHE.<h4>Objectives</h4>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.<h4>Methods</h4>Settings and participantsIt is an hospital-based registry established in centers 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. It is a secondary use of data which will be collected from the clinical records. The data collected for the registry will not entail further examinations or admissions to the facility and/or additional appointments to those normally provided for routine patient follow-up. VariablesFull details on patients and disease features, treatment and outcome will be collected, according to common clinical practice guidelines developed and shared with all the contributing centers. In addition, data on potential confounders (e.g. comorbidity; functional status etc.) will also be collected. Statistical methodsThe 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.<h4>Results</h4>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. |
| format | Article |
| id | doaj-art-437c63f0b21f4d4db2adca8416449656 |
| institution | DOAJ |
| issn | 1932-6203 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-437c63f0b21f4d4db2adca84164496562025-08-20T03:01:59ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-01198e030838710.1371/journal.pone.0308387The observational EURACAN prospective clinical registry dedicated to epithelioid hemangioendothelioma: The protocol of an international and collaborative effort on an ultra-rare entity.Anna Maria FrezzaHugh LeonardNinna Aggerholm-PedersenGiuseppe BadalamentiPaolo BailiGiacomo G BaldiSebastian BauerSerena BazzurriIrene BenzonelliAlexia BertuzziJean-Yves BlayGiuseppe BianchiSimone BonfarnuzzoChristophe BouvierKyetil BoyeJavier Martin BrotoAntonella BrunelloDomenico CampanacciPaolo G CasaliCarlo CicalaElisa CrottiLorenzo D'AmbrosioAngelo Paolo Dei TosNils DieckmannArmelle DufresneStephanie ElstonVirginia FerraresiStefano GabelliniClaudia GianiVincenzo GiannusaMelissa Gil SanjinesTeresa GrassaniAlessandro GronchiPaolo LasalviaStefan LindskogNadia HindiMatilde IngrossoAndrei IvanescuRobin JonesIwona LugowskaJulia KetzerAnna Mariuk-JaremaAlessandro MazzoccaLaura MonteleoneCarlo MorosiAndrea NapolitanoFrancesca NardozzaElisabetta NeriMaria NilssonAndri PapakonstantinouSandro PasqualiMarta SbaragliaFederico ScolariJoanna SzkanderaClaudia ValverdeBruno VincenziSalvatore VizzaccaroFederica ZuccheriSilvia StacchiottiAnnalisa Trama<h4>Introduction</h4>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.<h4>Study design</h4>Registry-based cohort study including only new cases of patients with a pathological and molecularly confirmed diagnosis of EHE.<h4>Objectives</h4>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.<h4>Methods</h4>Settings and participantsIt is an hospital-based registry established in centers 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. It is a secondary use of data which will be collected from the clinical records. The data collected for the registry will not entail further examinations or admissions to the facility and/or additional appointments to those normally provided for routine patient follow-up. VariablesFull details on patients and disease features, treatment and outcome will be collected, according to common clinical practice guidelines developed and shared with all the contributing centers. In addition, data on potential confounders (e.g. comorbidity; functional status etc.) will also be collected. Statistical methodsThe 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.<h4>Results</h4>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.https://doi.org/10.1371/journal.pone.0308387 |
| spellingShingle | Anna Maria Frezza Hugh Leonard Ninna Aggerholm-Pedersen Giuseppe Badalamenti Paolo Baili Giacomo G Baldi Sebastian Bauer Serena Bazzurri Irene Benzonelli Alexia Bertuzzi Jean-Yves Blay Giuseppe Bianchi Simone Bonfarnuzzo Christophe Bouvier Kyetil Boye Javier Martin Broto Antonella Brunello Domenico Campanacci Paolo G Casali Carlo Cicala Elisa Crotti Lorenzo D'Ambrosio Angelo Paolo Dei Tos Nils Dieckmann Armelle Dufresne Stephanie Elston Virginia Ferraresi Stefano Gabellini Claudia Giani Vincenzo Giannusa Melissa Gil Sanjines Teresa Grassani Alessandro Gronchi Paolo Lasalvia Stefan Lindskog Nadia Hindi Matilde Ingrosso Andrei Ivanescu Robin Jones Iwona Lugowska Julia Ketzer Anna Mariuk-Jarema Alessandro Mazzocca Laura Monteleone Carlo Morosi Andrea Napolitano Francesca Nardozza Elisabetta Neri Maria Nilsson Andri Papakonstantinou Sandro Pasquali Marta Sbaraglia Federico Scolari Joanna Szkandera Claudia Valverde Bruno Vincenzi Salvatore Vizzaccaro Federica Zuccheri Silvia Stacchiotti Annalisa Trama The observational EURACAN prospective clinical registry dedicated to epithelioid hemangioendothelioma: The protocol of an international and collaborative effort on an ultra-rare entity. PLoS ONE |
| title | The observational EURACAN prospective clinical registry dedicated to epithelioid hemangioendothelioma: The protocol of an international and collaborative effort on an ultra-rare entity. |
| title_full | The observational EURACAN prospective clinical registry dedicated to epithelioid hemangioendothelioma: The protocol of an international and collaborative effort on an ultra-rare entity. |
| title_fullStr | The observational EURACAN prospective clinical registry dedicated to epithelioid hemangioendothelioma: The protocol of an international and collaborative effort on an ultra-rare entity. |
| title_full_unstemmed | The observational EURACAN prospective clinical registry dedicated to epithelioid hemangioendothelioma: The protocol of an international and collaborative effort on an ultra-rare entity. |
| title_short | The observational EURACAN prospective clinical registry dedicated to epithelioid hemangioendothelioma: The protocol of an international and collaborative effort on an ultra-rare entity. |
| title_sort | observational euracan prospective clinical registry dedicated to epithelioid hemangioendothelioma the protocol of an international and collaborative effort on an ultra rare entity |
| url | https://doi.org/10.1371/journal.pone.0308387 |
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