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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00011208 |
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Date of registration:
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08/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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UMBRELLA Protocol SIOP-RTSG 2016 - Integrated research and guidelines for standardized diagnostics and therapy of kidney tumours in children, adolescents and young adults
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Scientific title:
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UMBRELLA Protocol SIOP-RTSG 2016 - Integrated research and guidelines for standardized diagnostics and therapy of kidney tumours in children, adolescents and young adults - UMBRELLA |
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Date of first enrolment:
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01/03/2019 |
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Target sample size:
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4000 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00011208 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: diagnostic
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Phase:
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Bosnia & Herzegovina
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Brazil
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Chile
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China
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Czechia
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Denmark
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Egypt
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Estonia
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Finland
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France
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Germany
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Greece
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Hungary
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Italy
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Japan
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Jordan
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Latvia
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Lithuania
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Netherlands
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Norway
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Poland
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Portugal
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Russia
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Serbia
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Singapore
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Slovakia
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Slovenia
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Spain
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Sweden
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Switzerland
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United Kingdom
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Contacts
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Name:
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Norbert
Graf |
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Address:
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Campus Homburg, Gebäude 9
66421
Homburg
Germany |
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Telephone:
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06841 1624711 |
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Email:
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graf@uks.eu |
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Affiliation:
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Klinik für Pädiatrische Onkologie und HämatologieUniversitätsklinikum Homburg |
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Name:
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Norbert
Graf |
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Address:
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Campus Homburg, Gebäude 9
66421
Homburg
Germany |
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Telephone:
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06841 1624711 |
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Email:
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graf@uks.eu |
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Affiliation:
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Klinik für Pädiatrische Onkologie und HämatologieUniversitätsklinikum Homburg |
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Key inclusion & exclusion criteria
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Inclusion criteria: All children with a kidney Tumor and adults with nephroblastom if they are diagnosed in a participating centre. Participating centres have to register all such pateints into the UMBRELLA SIOP-RTSG 2016 protocol
Exclusion criteria: Missing informed consent is the only exclusion criterion.
Age minimum:
None
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malignant neoplasm of kidney, except renal pelvis
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C64
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Intervention(s)
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Group 1: Treatment of the different kidney tumours is not a subject of the study. This is done according to SIOP 2001 (DRKS-ID of the study: DRKS00003769). The aim is to standardize diagnosis and and treatment in participating countries.
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Primary Outcome(s)
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Characterization of new biomarkers for diagnosis, prognosis and treatment
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Secondary Outcome(s)
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Standardization of diagnosis and treatment
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Secondary ID(s)
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U1111-1196-3034
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Source(s) of Monetary Support
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Elterninitiative krebskranke Kinder im Saarland e.V.
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Ethics review
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Status: Approved
Approval date: 21/12/2016
Contact:
ethikkommission@aeksaar.de
Ethikkommission bei der Ärztekammer des Saarlandes
+49-681-4003216
ethikkommission@aeksaar.de
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