Pediatric Disease Registry in Essential Thrombocythaemia (ET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01198717
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : March 15, 2016
Information provided by (Responsible Party):

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.

Condition or disease
Essential Thrombocythemia (ET)

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Multicentre Paediatric Disease Registry in Essential Thrombocythaemia
Study Start Date : September 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Primary Outcome Measures :
  1. Treatment effects on platelet count in children ages 6-17 years inclusive. [ Time Frame: 60 months ]

Secondary Outcome Measures :
  1. Drug utilization of cytoreductive therapy in children ages 6-17 years inclusive [ Time Frame: 60 months ]

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Paediatrics aged between 6 years and 17 years

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01198717

Czech Republic
Paediatric Clinic University Hospital Olomouc
Olomouc, Czech Republic, 77520
Clinic of Paediatric haematology and oncology University Hospital Motol
Prague, Czech Republic
Paediatric Oncology Unit, Hopital Cote De Nacre
Caen, France, 14033
Practicen Hospitalier , Institute d'Hematologie et Oncologie Pediatrique
Lyon, France, 69008
Centre Hospitalier Lyon Sud - service Hématologie
Pierre Benite, France, 69310
Hopitaux de Brabois
Vandoeuvre Les Nancy, France, 545511
Klinikum Chemnitz GmbH, Klinik für Kinder-und Jugendmedizin
Chemnitz, Germany, 09009
Zentrum für Kinder- und Jugendmedizin Klinik II / III
Frankfurt, Germany, 60590
"Agia Sophia" Children's Hospital
Athens, Greece, 11527
Dipartimento di Biomedicina dell'Eta Evolutiva. University of Bari
Bari, Italy
Servico de Oncoematologia Peditrica
Cagliari, Italy
UO Oncoematologia AOU Meyer
Florence, Italy, 50139
Pediatric Hamatology Unit. Department of Hematology and Oncology. G Gaslini Children's hospital. Largo
Genova, Italy
Chairmen of Pediatric Hamatooncology Outpatient Clinic. Hospital San Gerardo
Monza, Italy, 20052
Department of Oncology, Pausilipon Hospital, AORN Santobono
Napoli, Italy
Azienda Ospedaliera di Padova
Padova, Italy
Department of Cellular Biotechnologies and Hematology. Sapienza University
Rome, Italy, 00161
Ospedale Casa Sollievo della Sofferenza
San Giovanni, Italy
Hamatology Unit. Paediatric Department. University of Torino
Torino, Italy, 10126
Sección de Hematología Pediátrica. Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Universitario Mutua de Terrassa
Barcelona, Spain, 08221
Jefe de Servicio Oncología Y Hematología Pediátricas
Barcelona, Spain
Servicio de Hematología Clínica, Hospital Sant Joan de Déu Barcelona
Barcelona, Spain
Servicio de Transfusión, Hospital Universitario Niño Jesús
Madrid, Spain, 28009
Department Haematology, Hospital Ramon y Caja
Madrid, Spain
Hospital Universitario Virgen de la Arrixac
Murcia, Spain
Complexo Hospitalario Universitario, Santiago
Santiago de Compostela, Spain, 15706
Leitender Arzt, Pädiatrische Hämatologie/Onkologie Kinderspital
Luzern, Switzerland, CH-6000
United Kingdom
St James University Hospital
Leeds, United Kingdom
Royal Manchester Childrens Hospital,
Manchester, United Kingdom, M13 9Wl
Children's Clinic, Royal Berkshire Hospital
Reading, United Kingdom
Sheffield Childrens Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
Principal Investigator: Maria Randi Azienda Ospedaliera di Padova

Responsible Party: Shire Identifier: NCT01198717     History of Changes
Other Study ID Numbers: SPD422-404
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders