NCT01198717

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
8 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

September 28, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

5.4 years

First QC Date

September 8, 2010

Last Update Submit

March 16, 2021

Conditions

Essential Thrombocythemia (ET)

Outcome Measures

Primary Outcomes (1)

  • Treatment effects on platelet count in children ages 6-17 years inclusive.

    60 months

Secondary Outcomes (1)

  • Drug utilization of cytoreductive therapy in children ages 6-17 years inclusive

    60 months

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Paediatrics aged between 6 years and 17 years

You may qualify if:

  • \- 6 years or over and less than 18 years patient has ET according to the WHO criteria as guidance

You may not qualify if:

  • Interventional clinical study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Paediatric Clinic University Hospital Olomouc

Olomouc, 77520, Czechia

Location

Clinic of Paediatric haematology and oncology University Hospital Motol

Prague, Czechia

Location

Paediatric Oncology Unit, Hopital Cote De Nacre

Caen, 14033, France

Location

Practicen Hospitalier , Institute d'Hematologie et Oncologie Pediatrique

Lyon, 69008, France

Location

Centre Hospitalier Lyon Sud - service Hématologie

Pierre-Bénite, 69310, France

Location

Hopitaux de Brabois

Vandœuvre-lès-Nancy, 545511, France

Location

Klinikum Chemnitz GmbH, Klinik für Kinder-und Jugendmedizin

Chemnitz, 09009, Germany

Location

Zentrum für Kinder- und Jugendmedizin Klinik II / III

Frankfurt, 60590, Germany

Location

"Agia Sophia" Children's Hospital

Athens, 11527, Greece

Location

Dipartimento di Biomedicina dell'Eta Evolutiva. University of Bari

Bari, Italy

Location

Servico de Oncoematologia Peditrica

Cagliari, Italy

Location

UO Oncoematologia AOU Meyer

Florence, 50139, Italy

Location

Pediatric Hamatology Unit. Department of Hematology and Oncology. G Gaslini Children's hospital. Largo

Genova, Italy

Location

Chairmen of Pediatric Hamatooncology Outpatient Clinic. Hospital San Gerardo

Monza, 20052, Italy

Location

Department of Oncology, Pausilipon Hospital, AORN Santobono

Napoli, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Department of Cellular Biotechnologies and Hematology. Sapienza University

Rome, 00161, Italy

Location

Ospedale Casa Sollievo della Sofferenza

San Giovanni, Italy

Location

Hamatology Unit. Paediatric Department. University of Torino

Torino, 10126, Italy

Location

Sección de Hematología Pediátrica. Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario Mutua de Terrassa

Barcelona, 08221, Spain

Location

Jefe de Servicio Oncología Y Hematología Pediátricas

Barcelona, Spain

Location

Servicio de Hematología Clínica, Hospital Sant Joan de Déu Barcelona

Barcelona, Spain

Location

Servicio de Transfusión, Hospital Universitario Niño Jesús

Madrid, 28009, Spain

Location

Department Haematology, Hospital Ramon y Caja

Madrid, Spain

Location

Hospital Universitario Virgen de la Arrixac

Murcia, Spain

Location

Complexo Hospitalario Universitario, Santiago

Santiago de Compostela, 15706, Spain

Location

Leitender Arzt, Pädiatrische Hämatologie/Onkologie Kinderspital

Lucerne, CH-6000, Switzerland

Location

St James University Hospital

Leeds, United Kingdom

Location

Royal Manchester Childrens Hospital,

Manchester, M13 9Wl, United Kingdom

Location

Children's Clinic, Royal Berkshire Hospital

Reading, United Kingdom

Location

Sheffield Childrens Hospital

Sheffield, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Thrombocythemia, Essential

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombocytosisBlood Platelet DisordersMyeloproliferative DisordersBone Marrow DiseasesHemorrhagic Disorders

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 10, 2010

Study Start

September 28, 2010

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

DE(2)IT(10)GB(4)FR(4)ES(8)CZ(2)CH(1)GR(1)