Clinical trial NCT01198717: Pediatric Disease Registry in Essential Thrombocythaemia (ET)
Official title: Multicentre Paediatric Disease Registry in Essential Thrombocythaemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Thrombocythemia (ET)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paediatrics aged between 6 years and 17 years

Brief summary: The aim of this study is to evaluate the progression of ET in children (aged 6-17years inclusive) over a period of 5 years maximum. The study will also assess how children are diagnosed, treatment options for those children with symptoms and events related to their ET and the outcomes of those treatments.


Eligibility criteria: Inclusion Criteria:

- 6 years or over and less than 18 years patient has ET according to the WHO criteria as guidance

Exclusion Criteria:

* Interventional clinical study participation

Primary outcomes:
measure: Treatment effects on platelet count in children ages 6-17 years inclusive.
timeFrame: 60 months
Secondary outcomes:
measure: Drug utilization of cytoreductive therapy in children ages 6-17 years inclusive
timeFrame: 60 months
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Paediatric Clinic University Hospital Olomouc
city: Prague
country: Czechia
facility: Clinic of Paediatric haematology and oncology University Hospital Motol
city: Caen
country: France
facility: Paediatric Oncology Unit, Hopital Cote De Nacre
city: Lyon
country: France
facility: Practicen Hospitalier , Institute d'Hematologie et Oncologie Pediatrique
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud - service Hématologie
city: Vandoeuvre Les Nancy
country: France
facility: Hopitaux de Brabois
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz GmbH, Klinik für Kinder-und Jugendmedizin
city: Frankfurt
country: Germany
facility: Zentrum für Kinder- und Jugendmedizin Klinik II / III
city: Athens
country: Greece
facility: "Agia Sophia" Children's Hospital
city: Bari
country: Italy
facility: Dipartimento di Biomedicina dell'Eta Evolutiva. University of Bari
city: Cagliari
country: Italy
facility: Servico de Oncoematologia Peditrica
city: Florence
country: Italy
facility: UO Oncoematologia AOU Meyer
city: Genova
country: Italy
facility: Pediatric Hamatology Unit. Department of Hematology and Oncology. G Gaslini Children's hospital. Largo
city: Monza
country: Italy
facility: Chairmen of Pediatric Hamatooncology Outpatient Clinic. Hospital San Gerardo
city: Napoli
country: Italy
facility: Department of Oncology, Pausilipon Hospital, AORN Santobono
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Rome
country: Italy
facility: Department of Cellular Biotechnologies and Hematology. Sapienza University
city: San Giovanni
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
city: Torino
country: Italy
facility: Hamatology Unit. Paediatric Department. University of Torino
city: Barcelona
country: Spain
facility: Sección de Hematología Pediátrica. Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Mutua de Terrassa
city: Barcelona
country: Spain
facility: Jefe de Servicio Oncología Y Hematología Pediátricas
city: Barcelona
country: Spain
facility: Servicio de Hematología Clínica, Hospital Sant Joan de Déu Barcelona
city: Madrid
country: Spain
facility: Servicio de Transfusión, Hospital Universitario Niño Jesús
city: Madrid
country: Spain
facility: Department Haematology, Hospital Ramon y Caja
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixac
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario, Santiago
city: Luzern
country: Switzerland
facility: Leitender Arzt, Pädiatrische Hämatologie/Onkologie Kinderspital
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Childrens Hospital,
city: Reading
country: United Kingdom
facility: Children's Clinic, Royal Berkshire Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Childrens Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: