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

  1. 11/2/15 11/2/15 -
  2. 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

Registration
Description

Registration

Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Date of consent first parent
Description

Date of consent first parent

Data type

date

Alias
UMLS CUI [1]
C0600634
Date of consent second parent (UK: not necessary)
Description

Date of consent second parent (UK: not necessary)

Data type

date

Alias
UMLS CUI [1]
C0600634
Sex
Description

Sex

Data type

integer

Alias
UMLS CUI [1]
C0079399
Consent for blood sample for pharmacogenetic analysis
Description

Consent for blood sample for pharmacogenetic analysis

Data type

integer

Alias
UMLS CUI [1]
C0021430
Date of diagnosis
Description

Date of diagnosis

Data type

date

Alias
UMLS CUI [1]
C2316983
Tumour type
Description

Tumour type

Wilms tumour
Description

Wilms tumour SIOP Wilms tumour study group (e.g. SIOP WT 2001)

Data type

integer

Alias
UMLS CUI [1]
C0027708
Neuroblastoma
Description

Neuroblastoma

Data type

integer

Alias
UMLS CUI [1]
C0027819
Ewing sarcoma
Description

Ewing sarcoma

Data type

integer

Alias
UMLS CUI [1]
C0553580
Soft tissue sarcoma
Description

Soft tissue sarcoma

Data type

integer

Alias
UMLS CUI [1]
C0334449
ALL
Description

ALL

Data type

integer

Alias
UMLS CUI [1]
C0027651
Other
Description

Other

Data type

integer

Alias
UMLS CUI [1]
C0027651
Doxorubicin administration: time of infusion
Description

Doxorubicin administration: time of infusion

Is the planned infusion time in accordance with the above listed infusion time (taken from the protocol)?
Description

Is the planned infusion time in accordance with the above listed infusion time (taken from the protocol)?

Data type

integer

Alias
UMLS CUI [1]
C0574032
Inclusion criteria
Description

Inclusion criteria

Patient ≤ 17 years of age
Description

Patient ≤ 17 years of age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Patient shall receive at least two cycles of doxorubicin
Description

Patient shall receive at least two cycles of doxorubicin

Data type

boolean

Alias
UMLS CUI [1]
C0013089
Patient, parent(s) or legal representative has/have provided written informed consent to participate in the trial according to national regulations
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
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
Description

Patient is enrolled in a national or European protocol

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Life expectancy of at least 3 month
Description

Life expectancy of at least 3 month

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Karnofsky performance status of ≥ 70%
Description

Karnofsky performance status of ≥ 70%

Data type

boolean

Alias
UMLS CUI [1]
C3829424
Additional blood withdrawal is acceptable for the patient
Description

Additional blood withdrawal is acceptable for the patient

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Assent of patient, if patient is able to (if not able: please enter „N.A.“)
Description

Assent of patient, if patient is able to (if not able: please enter „N.A.“)

Data type

integer

Alias
UMLS CUI [1]
C1879749
Exclusion criterion
Description

Exclusion criterion

Prior cardiac problems
Description

Prior cardiac problems

Data type

boolean

Alias
UMLS CUI [1]
C0262402
Footer module
Description

Footer module

Date of registration
Description

Date of registration

Data type

date

Alias
UMLS CUI [1]
C2985881
Name Investigator
Description

Name Investigator

Data type

integer

Alias
UMLS CUI [1]
C2826892
Signature Investigator
Description

Signature Investigator

Data type

integer

Alias
UMLS CUI [1]
C2346576

Similar models

Registration

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Registration
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])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Code List
Sex
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])
Item Group
Tumour type
Item
Wilms tumour
integer
C0027708 (UMLS CUI [1])
Code List
Wilms tumour
CL Item
AVD (1)
CL Item
High Risk (2)
Item
Neuroblastoma
integer
C0027819 (UMLS CUI [1])
Code List
Neuroblastoma
CL Item
N4 (1)
CL Item
N6 (2)
CL Item
TVD (3)
CL Item
CADO (4)
Item
Ewing sarcoma
integer
C0553580 (UMLS CUI [1])
Code List
Ewing sarcoma
CL Item
VIDE (1)
CL Item
VAC (2)
CL Item
VAI (3)
Item
Soft tissue sarcoma
integer
C0334449 (UMLS CUI [1])
Code List
Soft tissue sarcoma
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) )
Item
ALL
integer
C0027651 (UMLS CUI [1])
Code List
ALL
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)
Item
Other
integer
C0027651 (UMLS CUI [1])
Code List
Other
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)
Item Group
Inclusion criteria
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)
Item Group
Exclusion criterion
Prior cardiac problems
Item
Prior cardiac problems
boolean
C0262402 (UMLS CUI [1])
Item Group
Footer module
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])

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