Essential Thrombocythemia (ET)NCT01198717
Pediatric Disease Registry in Essential Thrombocythaemia (ET)
An observational study of Essential Thrombocythemia (ET), run by Shire at 32 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Essential Thrombocythemia (ET)
- How many people
- 60 participants
- Where
- 32 sitesin 8 countries
- Study dates
- 28 Sep 2010to 1 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Paediatrics aged between 6 years and 17 years
Who may be able to join
- 6 years or over and less than 18 years patient has ET according to the WHO criteria as guidance
Who cannot join
- Interventional clinical study participation
Trial locations and contacts
32 sites in 8 countries.
32 sites in 8 countries
Italy10 sites
Dipartimento di Biomedicina dell'Eta Evolutiva. University of Bari
Bari
Servico de Oncoematologia Peditrica
Cagliari
UO Oncoematologia AOU Meyer
Florence, 50139
Pediatric Hamatology Unit. Department of Hematology and Oncology. G Gaslini Children's hospital. Largo
Genova
Chairmen of Pediatric Hamatooncology Outpatient Clinic. Hospital San Gerardo
Monza, 20052
Department of Oncology, Pausilipon Hospital, AORN Santobono
Naples
Azienda Ospedaliera di Padova
Padova
Department of Cellular Biotechnologies and Hematology. Sapienza University
Rome, 00161
Ospedale Casa Sollievo della Sofferenza
San Giovanni
Hamatology Unit. Paediatric Department. University of Torino
Torino, 10126
Spain8 sites
Sección de Hematología Pediátrica. Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitario Mutua de Terrassa
Barcelona, 08221
Jefe de Servicio Oncología Y Hematología Pediátricas
Barcelona
Servicio de Hematología Clínica, Hospital Sant Joan de Déu Barcelona
Barcelona
Servicio de Transfusión, Hospital Universitario Niño Jesús
Madrid, 28009
Department Haematology, Hospital Ramon y Caja
Madrid
Hospital Universitario Virgen de la Arrixac
Murcia
Complexo Hospitalario Universitario, Santiago
Santiago de Compostela, 15706
France4 sites
Paediatric Oncology Unit, Hopital Cote De Nacre
Caen, 14033
Practicen Hospitalier , Institute d'Hematologie et Oncologie Pediatrique
Lyon, 69008
Centre Hospitalier Lyon Sud - service Hématologie
Pierre-Bénite, 69310
Hopitaux de Brabois
Vandœuvre-lès-Nancy, 545511
United Kingdom4 sites
St James University Hospital
Leeds
Royal Manchester Childrens Hospital,
Manchester, M13 9Wl
Children's Clinic, Royal Berkshire Hospital
Reading
Sheffield Childrens Hospital
Sheffield
Czechia2 sites
Paediatric Clinic University Hospital Olomouc
Olomouc, 77520
Clinic of Paediatric haematology and oncology University Hospital Motol
Prague
Germany2 sites
Klinikum Chemnitz GmbH, Klinik für Kinder-und Jugendmedizin
Chemnitz, 09009
Zentrum für Kinder- und Jugendmedizin Klinik II / III
Frankfurt, 60590
Switzerland1 site
Leitender Arzt, Pädiatrische Hämatologie/Onkologie Kinderspital
Lucerne, CH-6000
About this study
Official title: 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.
- Conditions
- Essential Thrombocythemia (ET)
- Medical subject headings
- Thrombocythemia, Essential
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effects on platelet count in children ages 6-17 years inclusive.
Measured: 60 months
Secondary outcomes (1)
Drug utilization of cytoreductive therapy in children ages 6-17 years inclusive
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study start28 Sep 2010
- Primary completion1 Mar 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential Thrombocythemia (ET)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198717
- Sponsor's protocol ID
- SPD422-404
- Status last verified
- Mar 2021
- First submitted
- 8 Sep 2010
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Paediatric Disease Registry in Essential Thrombocythaemia
- ClinicalTrials.gov ID
- NCT01198717
- Acronym / sponsor ID
- SPD422-404
- Conditions
- Essential Thrombocythemia (ET)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2010 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Paediatrics aged between 6 years and 17 years
Key inclusion criteria (1 listed)
- 6 years or over and less than 18 years patient has ET according to the WHO criteria as guidance
Key exclusion criteria (1 listed)
- Interventional clinical study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment effects on platelet count in children ages 6-17 years inclusive.
Time frame: 60 months
1 secondary outcome
Drug utilization of cytoreductive therapy in children ages 6-17 years inclusive
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
32 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Thrombocythemia (ET), run by Shire at 32 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Italy, Spain, France, United Kingdom, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effects on platelet count in children ages 6-17 years inclusive. (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.