Pediatric Disease Registry in Essential Thrombocythaemia (ET)
This study is ongoing, but not recruiting participants.
Sponsor:
Shire Development LLC
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01198717
First received: September 8, 2010
Last updated: April 25, 2013
Last verified: April 2013
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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 Development LLC:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198717
Locations
| Czech Republic | |
| Paediatric Clinical University Hospital I.P | |
| Olomouc, Czech Republic, 77520 | |
| Clinical of Paediatric haematology and oncology. Logy University Hospital | |
| 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 | |
| Hopitaux de Brabois | |
| Vandoeuvre Les Nancy, France, 545511 | |
| Germany | |
| Klinikum Chemnitz GmbH, Klinik fur Kinder-und Jegendmedizein | |
| Chemnitz, Germany, 09009 | |
| Zentrum für Kinder- und Jugendmedizin Klinik II / III | |
| Frankfurt, Germany, 60590 | |
| Greece | |
| University of Athens 'Agia Sofia' Childresn Hospital | |
| Goudi, Athens, Greece, 11521 | |
| Agia Sofia Children's Hospital | |
| Athens, Greece | |
| 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 | |
| John Radcliffe Hospital, Hematology dept | |
| Oxford, United Kingdom | |
| Sheffield Childrens Hospital | |
| Sheffield, United Kingdom | |
Sponsors and Collaborators
Shire Development LLC
Investigators
| Principal Investigator: | Maria L Randi | Azienda Ospedaliera di Padova |
More Information
No publications provided
| Responsible Party: | Shire Development LLC |
| ClinicalTrials.gov Identifier: | NCT01198717 History of Changes |
| Other Study ID Numbers: | SPD422-404 |
| Study First Received: | September 8, 2010 |
| Last Updated: | April 25, 2013 |
| 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 May 16, 2013