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ID
12285
Beschreibung
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
Stichworte
Versionen (2)
- 02.11.15 02.11.15 -
- 27.09.21 27.09.21 -
Hochgeladen am
2. November 2015
DOI
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Lizenz
Creative Commons BY 4.0
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Pharmacokinetic Study of Doxorubicin in Children With Cancer DRKS00003787 NCT01095926
Registration
- StudyEvent: ODM
Ähnliche Modelle
Registration
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Date of consent first parent
Item
Date of consent first parent
date
C0600634 (UMLS CUI [1])
Date of consent second parent
Item
Date of consent second parent (UK: not necessary)
date
C0600634 (UMLS CUI [1])
CL Item
male (1)
CL Item
female (2)
Item
Consent for blood sample for pharmacogenetic analysis
integer
C0021430 (UMLS CUI [1])
Code List
Consent for blood sample for pharmacogenetic analysis
CL Item
yes (1)
CL Item
no (2)
CL Item
"If yes, please document date of blood sample on page 39 „Pharmacogenetics“ (4)
Date of diagnosis
Item
Date of diagnosis
date
C2316983 (UMLS CUI [1])
CL Item
AVD (1)
CL Item
High Risk (2)
CL Item
N4 (1)
CL Item
N6 (2)
CL Item
TVD (3)
CL Item
CADO (4)
CL Item
VIDE (1)
CL Item
VAC (2)
CL Item
VAI (3)
CL Item
10 - VAIA III (CWS (e.g. CWS-2002-P) )
CL Item
11 - High risk (EpSSG-Rhabdomyosarcoma (e.g. RMS 2005) )
CL Item
12 - IA (EpSSG-Soft tissue sarcoma (e.g. NRSTS 2005) )
CL Item
I-BFM (e.g. ALL-BFM 2000) = 13 - Protocol II (1)
CL Item
AIEOP (e.g. LLA 2000) = 14 - Protocol II (2)
CL Item
AIEOP/I-BFM (AIEOP-BFM ALL2009) = 15 - Protocol II (3)
CL Item
SFCE (FRALLE 2000) = 16 - Consolidation ; 17 - Intensification (4)
CL Item
MRC (e.g. UKALL 2003) = 18 - Delayed Intensification (5)
CL Item
To include a patient with another tumour type is only possible if the patient is younger than 3 years! (1)
CL Item
Please contact the national study manager to verify if patient is eligible. (2)
Item Group
Doxorubicin administration: time of infusion
Item
Is the planned infusion time in accordance with the above listed infusion time (taken from the protocol)?
integer
C0574032 (UMLS CUI [1])
Code List
Is the planned infusion time in accordance with the above listed infusion time (taken from the protocol)?
CL Item
Yes (protocol specific sampling sheets will be provided) (1)
CL Item
No, deviations are planned (one of three flexible standard sheets will be provided) (2)
CL Item
If no: administered infusion time: ≤ 0.5 h; > 0.5 h - < 12 h; ≥ 12 h (3)
Patient ≤ 17 years of age
Item
Patient ≤ 17 years of age
boolean
C0001779 (UMLS CUI [1])
Patient shall receive at least two cycles of doxorubicin
Item
Patient shall receive at least two cycles of doxorubicin
boolean
C0013089 (UMLS CUI [1])
Patient, parent(s) or legal representative has/have provided written informed consent to participate in the trial according to national regulations
Item
Patient, parent(s) or legal representative has/have provided written informed consent to participate in the trial according to national regulations
boolean
C0021430 (UMLS CUI [1])
Patient is enrolled in a national or European protocol
Item
Patient is enrolled in a national or European protocol - run by one of the study groups listed in the protocol - for treatment of Wilms tumours, neuroblastoma, soft tissue sarcoma, Ewing sarcoma or acute lymphatic leukaemia and is treated with doxorubicin according to that protocol Or Patient < 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy. Treatment with doxorubicin has to be according to that protocol
boolean
C2348568 (UMLS CUI [1])
Life expectancy of at least 3 month
Item
Life expectancy of at least 3 month
boolean
C0023671 (UMLS CUI [1])
Karnofsky performance status of ≥ 70%
Item
Karnofsky performance status of ≥ 70%
boolean
C3829424 (UMLS CUI [1])
Additional blood withdrawal is acceptable for the patient
Item
Additional blood withdrawal is acceptable for the patient
boolean
C0005834 (UMLS CUI [1])
Item
Assent of patient, if patient is able to (if not able: please enter „N.A.“)
integer
C1879749 (UMLS CUI [1])
Code List
Assent of patient, if patient is able to (if not able: please enter „N.A.“)
CL Item
Yes (1)
CL Item
No (2)
CL Item
N.A. (3)
CL Item
If assent is given: Date of patient assent (4)
Prior cardiac problems
Item
Prior cardiac problems
boolean
C0262402 (UMLS CUI [1])
Date of registration
Item
Date of registration
date
C2985881 (UMLS CUI [1])
Name Investigator
Item
Name Investigator
integer
C2826892 (UMLS CUI [1])
Signature Investigator
Item
Signature Investigator
integer
C2346576 (UMLS CUI [1])