Spots Global Cancer Trial Database for Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera
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Trial Identification
Brief Title: Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera
Official Title: Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera
Study ID: NCT06078319
Interventions
Study Description
Brief Summary: The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The main purpose is to assess adherence to ruxolitinib using the ARMS questionnaire. Each individual patient will be administered the questionnaire at the first convenient opportunity, regardless of when ruxolitinib is started, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement.
Detailed Description: The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Laboratory tests and histologic, cytogenetic, molecular, and radiologic investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular, data related to systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. These data will be collected at the first administration of the ARMS questionnaire and again after 12, 24, and 48 weeks. If performed, any additional assessments will also be recorded. Each individual patient will be administered the questionnaire (ARMS) at the first convenient opportunity, regardless of the time of initiation of ruxolitinib, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement. If in-person data collection is not possible, the mode of data collection by telephone interview will be adopted. The minimum expected duration of individual patient observation is 48 weeks.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Azienda Ospedaliera Annunziata, Cosenza, Calabria, Italy
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli", Reggio Calabria, Calabria, Italy
Università degli Studi di Napoli Federico II - U.O.C. di Ematologia e Trapianti di midollo, Napoli, Campania, Italy
IRCCS Policlinico Sant'Orsola, Bologna, Emilia Romagna, Italy
Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna, Ferrara, Emilia-Romagna, Italy
Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy
AUSL di Piacenza - Palazzine Medicine Specialistiche, Piacenza, Emilia-Romagna, Italy
Dipartimento Oncoematologico - AUSL della Romagna, Ravenna, Emilia-Romagna, Italy
Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, Emilia-Romagna, Italy
Ospedale Infermi di Rimini, Rimini, Emilia-Romagna, Italy
A.O.U. Integrata di Udine, Udine, Friuli-Venezia Giulia, Italy
Ospedale S. Eugenio, Roma, Lazio, Italy
A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza", Roma, Lazio, Italy
Ospedale Belcolle, Viterbo, Lazio, Italy
IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST, Genova, Liguria, Italy
ASST Spedali Civili di Brescia, Brescia, Lombardia, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Lombardia, Italy
Ospedale San Gerardo, Monza, Lombardia, Italy
A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore, Pesaro, Marche, Italy
Ospedale San Luigi Gonzaga, Orbassano, Piemonte, Italy
Department of Oncology, University of Torino, Torino, Piemonte, Italy
A.O.U. Città della Salute e della Scienza - Presidio Molinette, Torino, Piemonte, Italy
A. O. Ordine Mauriziano di Torino, Torino, Piemonte, Italy
Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari, Cagliari, Sardegna, Italy
A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto, Catania, Sicilia, Italy
Policlinico S.Maria alle Scotte, Siena, Toscana, Italy
AOU di Padova, Padova, Veneto, Italy
A.O.U. Integrata Verona - Borgo Roma, Verona, Veneto, Italy
Contact Details
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