Pediatric Disease Registry in Essential Thrombocythaemia (ET)

March 16, 2021 updated by: Shire

Multicentre Paediatric Disease Registry in Essential Thrombocythaemia

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Paediatrics aged between 6 years and 17 years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment effects on platelet count in children ages 6-17 years inclusive.
Time Frame: 60 months
60 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Drug utilization of cytoreductive therapy in children ages 6-17 years inclusive
Time Frame: 60 months
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2010

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD422-404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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