ID
44713
Description
Official Title: Phase II Pharmacokinetic Study to Assess the Age-dependency in the Clearance of Doxorubicin in Paediatric Patients With Solid Tumours and Leukaemia Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity. https://clinicaltrials.gov/ct2/show/NCT01095926 NCT01095926
Link
https://clinicaltrials.gov/ct2/show/NCT01095926
Keywords
Versions (2)
- 11/2/15 11/2/15 -
- 9/27/21 9/27/21 -
Uploaded on
September 27, 2021
DOI
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License
Creative Commons BY 4.0
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Pharmacokinetic Study of Doxorubicin in Children With Cancer DRKS00003787 NCT01095926
Registration
- StudyEvent: ODM
Description
Tumour type
Description
Wilms tumour SIOP Wilms tumour study group (e.g. SIOP WT 2001)
Data type
integer
Alias
- UMLS CUI [1]
- C0027708
Description
Neuroblastoma
Data type
integer
Alias
- UMLS CUI [1]
- C0027819
Description
Ewing sarcoma
Data type
integer
Alias
- UMLS CUI [1]
- C0553580
Description
Soft tissue sarcoma
Data type
integer
Alias
- UMLS CUI [1]
- C0334449
Description
ALL
Data type
integer
Alias
- UMLS CUI [1]
- C0027651
Description
Other
Data type
integer
Alias
- UMLS CUI [1]
- C0027651
Description
Doxorubicin administration: time of infusion
Description
Inclusion criteria
Description
Patient ≤ 17 years of age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Patient shall receive at least two cycles of doxorubicin
Data type
boolean
Alias
- UMLS CUI [1]
- C0013089
Description
Patient, parent(s) or legal representative has/have provided written informed consent to participate in the trial according to national regulations
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Patient is enrolled in a national or European protocol
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Life expectancy of at least 3 month
Data type
boolean
Alias
- UMLS CUI [1]
- C0023671
Description
Karnofsky performance status of ≥ 70%
Data type
boolean
Alias
- UMLS CUI [1]
- C3829424
Description
Additional blood withdrawal is acceptable for the patient
Data type
boolean
Alias
- UMLS CUI [1]
- C0005834
Description
Assent of patient, if patient is able to (if not able: please enter „N.A.“)
Data type
integer
Alias
- UMLS CUI [1]
- C1879749
Description
Exclusion criterion
Description
Footer module
Similar models
Registration
- StudyEvent: ODM