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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Hopitaux 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings