ID

5150

Description

ODM derived from http://clinicaltrials.gov/show/NCT01423747

Link

http://clinicaltrials.gov/show/NCT01423747

Keywords

Versions (2)
  1. 4/17/13 4/17/13 - Martin Dugas
  2. 4/20/14 4/20/14 - Julian Varghese
Uploaded on

April 20, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01423747 Lymphoblastic Leukemia, Acute, Childhood

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age 3 Months to 18 Years
Description

age 3 Months to 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Lymphoblastic Leukemia, Acute, Childhood
Description

Lymphoblastic Leukemia, Acute, Childhood

Data type

boolean

Alias
UMLS CUI 2011AA
C0023452
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
age at time of initial diagnosis or relapse diagnosis, respectively under or equal 18 years
Description

age at time of initial diagnosis or relapse diagnosis, respectively under or equal 18 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
indication for allogeneic HSCT
Description

indication for allogeneic HSCT

Data type

boolean

Alias
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
complete remission before HSCT
Description

complete remission before HSCT

Data type

boolean

Alias
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
Description

written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form

Data type

boolean

Alias
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0009797
UMLS CUI 2011AA
C0030551
SNOMED CT 2011_0131
40683002
HL7 V3 2006_05
PARNT
UMLS CUI 2011AA
C0023226
SNOMED CT 2011_0131
58626002
LOINC Version 232
MTHU020628
UMLS CUI 2011AA
C0026193
SNOMED CT 2011_0131
410599005
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
Not Pregnant, Non-pregnant state
Description

no pregnancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
SNOMED CT 2011_0131
60001007
no secondary malignancy
Description

no secondary malignancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0027627
SNOMED CT 2011_0131
128462008
no previous HSCT
Description

no previous HSCT

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
HSCT is performed in a study participating centre.
Description

HSCT is performed in a study participating centre.

Data type

boolean

Alias
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205099
SNOMED CT 2011_0131
26216008
Exclusion Criteria
Description

Exclusion Criteria

age at time of initial diagnosis or relapse diagnosis, respectively above 18 years
Description

age at time of initial diagnosis or relapse diagnosis, respectively above 18 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
no indication for allogeneic HSCT
Description

no indication for allogeneic HSCT

Data type

boolean

Alias
UMLS CUI 2011AA
C0521090
SNOMED CT 2011_0131
71653005
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
no complete remission before SCT
Description

no complete remission before SCT

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1504389
MedDRA 14.1
10063581
no written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
Description

no written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form

Data type

boolean

Alias
UMLS CUI 2011AA
C1705492
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0009797
UMLS CUI 2011AA
C0030551
SNOMED CT 2011_0131
40683002
HL7 V3 2006_05
PARNT
UMLS CUI 2011AA
C0023226
SNOMED CT 2011_0131
58626002
LOINC Version 232
MTHU020628
UMLS CUI 2011AA
C0026193
SNOMED CT 2011_0131
410599005
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
Pregnancy, Gestation
Description

pregnancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Secondary malignant neoplastic disease
Description

secondary malignancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0027627
SNOMED CT 2011_0131
128462008
previous HSCT
Description

previous HSCT

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
HSCT is not performed in a study participating centre.
Description

HSCT is not performed in a study participating centre.

Data type

boolean

Alias
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205099
SNOMED CT 2011_0131
26216008
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age 3 Months to 18 Years
Item
age 3 Months to 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Lymphoblastic Leukemia, Acute, Childhood
Item
Lymphoblastic Leukemia, Acute, Childhood
boolean
C0023452 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
age at time of initial diagnosis or relapse diagnosis, respectively under or equal 18 years
Item
age at time of initial diagnosis or relapse diagnosis, respectively under or equal 18 years
boolean
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
indication for allogeneic HSCT
Item
indication for allogeneic HSCT
boolean
CL335836 (UMLS CUI 2011AA)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
complete remission before HSCT
Item
complete remission before HSCT
boolean
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
Item
written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
boolean
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0009797 (UMLS CUI 2011AA)
C0030551 (UMLS CUI 2011AA)
40683002 (SNOMED CT 2011_0131)
PARNT (HL7 V3 2006_05)
C0023226 (UMLS CUI 2011AA)
58626002 (SNOMED CT 2011_0131)
MTHU020628 (LOINC Version 232)
C0026193 (UMLS CUI 2011AA)
410599005 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
no pregnancy
Item
Not Pregnant, Non-pregnant state
boolean
C0549206 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
no secondary malignancy
Item
no secondary malignancy
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0027627 (UMLS CUI 2011AA)
128462008 (SNOMED CT 2011_0131)
no previous HSCT
Item
no previous HSCT
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
HSCT is performed in a study participating centre.
Item
HSCT is performed in a study participating centre.
boolean
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205099 (UMLS CUI 2011AA)
26216008 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
age at time of initial diagnosis or relapse diagnosis, respectively above 18 years
Item
age at time of initial diagnosis or relapse diagnosis, respectively above 18 years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
no indication for allogeneic HSCT
Item
no indication for allogeneic HSCT
boolean
C0521090 (UMLS CUI 2011AA)
71653005 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
no complete remission before SCT
Item
no complete remission before SCT
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1504389 (UMLS CUI 2011AA)
10063581 (MedDRA 14.1)
no written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
Item
no written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
boolean
C1705492 (UMLS CUI 2011AA)
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0009797 (UMLS CUI 2011AA)
C0030551 (UMLS CUI 2011AA)
40683002 (SNOMED CT 2011_0131)
PARNT (HL7 V3 2006_05)
C0023226 (UMLS CUI 2011AA)
58626002 (SNOMED CT 2011_0131)
MTHU020628 (LOINC Version 232)
C0026193 (UMLS CUI 2011AA)
410599005 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
pregnancy
Item
Pregnancy, Gestation
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
secondary malignancy
Item
Secondary malignant neoplastic disease
boolean
C0027627 (UMLS CUI 2011AA)
128462008 (SNOMED CT 2011_0131)
previous HSCT
Item
previous HSCT
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
HSCT is not performed in a study participating centre.
Item
HSCT is not performed in a study participating centre.
boolean
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
C1518422 (UMLS CUI 2011AA)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205099 (UMLS CUI 2011AA)
26216008 (SNOMED CT 2011_0131)
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