Pediatric Disease Registry in Essential Thrombocythaemia (ET)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01198717
First received: September 8, 2010
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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
Essential Thrombocythemia (ET)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Multicentre Paediatric Disease Registry in Essential Thrombocythaemia

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Treatment effects on platelet count in children ages 6-17 years inclusive. [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug utilization of cytoreductive therapy in children ages 6-17 years inclusive [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Paediatrics aged between 6 years and 17 years

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198717

Locations
Czech Republic
Paediatric Clinic University Hospital Olomouc
Olomouc, Czech Republic, 77520
Clinic of Paediatric haematology and oncology University Hospital Motol
Prague, Czech Republic
France
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
Germany
Klinikum Chemnitz GmbH, Klinik für Kinder-und Jugendmedizin
Chemnitz, Germany, 09009
Zentrum für Kinder- und Jugendmedizin Klinik II / III
Frankfurt, Germany, 60590
Greece
"Agia Sophia" Children's Hospital
Athens, Greece, 11527
Italy
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
Spain
Servicio de Hematología Clínica, Hospital Sant Joan de Déu Barcelona
Barcelona, Spain
Jefe de Servicio Oncología Y Hematología Pediátricas
Barcelona, Spain
Sección de Hematología Pediátrica. Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
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
Switzerland
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
Shire
Investigators
Principal Investigator: Maria L Randi Azienda Ospedaliera di Padova
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01198717     History of Changes
Other Study ID Numbers: SPD422-404
Study First Received: September 8, 2010
Last Updated: March 27, 2014
Health Authority: Italy: Ethics Committee
France: Institutional Ethical Committee
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on August 21, 2014