Pediatric Disease Registry in Essential Thrombocythaemia (ET)

Completed

• Conditions: Essential Thrombocythemia (ET)

• Registration Number: NCT01198717
• Lead Sponsor: Shire

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-10
• Study Start: 2010-09-28
• Primary Completion: 2016-03-01
• Study Completion: 2016-03-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment effects on platelet count in children ages 6-17 years inclusive.	60 months

Secondary Outcome Measures

Name	Time	Method
Drug utilization of cytoreductive therapy in children ages 6-17 years inclusive	60 months

Trial Locations

Locations (32)

Royal Manchester Childrens Hospital,; 🇬🇧 Manchester, United Kingdom

Paediatric Clinic University Hospital Olomouc; 🇨🇿 Olomouc, Czechia

Paediatric Oncology Unit, Hopital Cote De Nacre; 🇫🇷 Caen, France

Clinic of Paediatric haematology and oncology University Hospital Motol; 🇨🇿 Prague, Czechia

Practicen Hospitalier , Institute d'Hematologie et Oncologie Pediatrique; 🇫🇷 Lyon, France

Centre Hospitalier Lyon Sud - service Hématologie; 🇫🇷 Pierre Benite, France

Hopitaux de Brabois; 🇫🇷 Vandoeuvre Les Nancy, France

Klinikum Chemnitz GmbH, Klinik für Kinder-und Jugendmedizin; 🇩🇪 Chemnitz, Germany

Zentrum für Kinder- und Jugendmedizin Klinik II / III; 🇩🇪 Frankfurt, Germany

"Agia Sophia" Children's Hospital; 🇬🇷 Athens, Greece

Servico de Oncoematologia Peditrica; 🇮🇹 Cagliari, Italy

Dipartimento di Biomedicina dell'Eta Evolutiva. University of Bari; 🇮🇹 Bari, Italy

UO Oncoematologia AOU Meyer; 🇮🇹 Florence, Italy

Pediatric Hamatology Unit. Department of Hematology and Oncology. G Gaslini Children's hospital. Largo; 🇮🇹 Genova, Italy

Department of Cellular Biotechnologies and Hematology. Sapienza University; 🇮🇹 Rome, Italy

Chairmen of Pediatric Hamatooncology Outpatient Clinic. Hospital San Gerardo; 🇮🇹 Monza, Italy

Department of Oncology, Pausilipon Hospital, AORN Santobono; 🇮🇹 Napoli, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Sección de Hematología Pediátrica. Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hamatology Unit. Paediatric Department. University of Torino; 🇮🇹 Torino, Italy

Hospital Universitario Mutua de Terrassa; 🇪🇸 Barcelona, Spain

Ospedale Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni, Italy

Jefe de Servicio Oncología Y Hematología Pediátricas; 🇪🇸 Barcelona, Spain

Servicio de Transfusión, Hospital Universitario Niño Jesús; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de la Arrixac; 🇪🇸 Murcia, Spain

Servicio de Hematología Clínica, Hospital Sant Joan de Déu Barcelona; 🇪🇸 Barcelona, Spain

Complexo Hospitalario Universitario, Santiago; 🇪🇸 Santiago de Compostela, Spain

Children's Clinic, Royal Berkshire Hospital; 🇬🇧 Reading, United Kingdom

Sheffield Childrens Hospital; 🇬🇧 Sheffield, United Kingdom

Department Haematology, Hospital Ramon y Caja; 🇪🇸 Madrid, Spain

St James University Hospital; 🇬🇧 Leeds, United Kingdom

Leitender Arzt, Pädiatrische Hämatologie/Onkologie Kinderspital; 🇨🇭 Luzern, Switzerland