ID

42032

Beschrijving

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Registry Formular (Please send this to study centre until Day 8) Clinical Trial Number: NCT01117441.

Trefwoorden

Versies (2)
  1. 21-05-16 21-05-16 -
  2. 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
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15 maart 2021

DOI

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Creative Commons BY-NC-ND 3.0
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Registry Formular AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

Engels

Registry Formular AIEOP-BFM ALL 2009 NCT01117441

1 Formulieren  
Patient Information
Beschrijving

Patient Information

Alias
UMLS CUI-1
C1955348
Patient name
Beschrijving

Patient name

Datatype

text

Alias
UMLS CUI [1]
C1299487
Patient Birth Date
Beschrijving

Patient Birth Date

Datatype

date

Alias
UMLS CUI [1]
C0421451
Patient's gender
Beschrijving

Gender

Datatype

text

Alias
UMLS CUI [1]
C0079399
Date of diagnosis
Beschrijving

Date of diagnosis

Datatype

date

Alias
UMLS CUI [1]
C2316983
Therapy start date (start of pre-phase)
Beschrijving

Therapy start date

Datatype

date

Alias
UMLS CUI [1]
C3173309
Eligibility Criteria
Beschrijving

Eligibility Criteria

Alias
UMLS CUI-1
C0013893
Diagnosis of primary ALL
Beschrijving

Diagnosis of primary ALL

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C0011900
Exclusion of BCR/ABL-rearrangement or translocation t(9;22)?
Beschrijving

BCR/ABL-rearrangement or t(9;22)

Datatype

boolean

Alias
UMLS CUI [1]
C0004891
UMLS CUI [2]
C3897138
Exclusion of pregnancy or nursing?
Beschrijving

Pregnancy or nursing

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Does patient participate in another study trial? (Except for associated studies)
Beschrijving

Study Participation status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
Informed consent given by person who has custody of child (if patient > 15 y/o, informed consent given by patient himself/ herself) to participate in study and data storage
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Did patient receive steroids (longer than 2 weeks; dosage >= 1 mg/kg/d) or cytostatics 4 weeks before diagnosis?
Beschrijving

Steroid therapy and chemotherapy regimen

Datatype

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2]
C0392920
Does the patient has any comorbidity which is interferring with study protocol?
Beschrijving

Comorbidity affecting study protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348563
If Patient received steroid therapy (longer than 2 weeks; dosage >= 1 mg/kg/d) or cytostatics 4 weeks before diagnosis, specify:
Beschrijving

If Patient received steroid therapy (longer than 2 weeks; dosage >= 1 mg/kg/d) or cytostatics 4 weeks before diagnosis, specify:

Alias
UMLS CUI-1
C0149783
UMLS CUI-2
C0392920
Specify steroid therapy and chemotherapy regimen:
Beschrijving

Steroid therapy and chemotherapy regimen: Specification

Datatype

text

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C2348235
Specify received daily dose:
Beschrijving

Daily Dose

Datatype

float

Alias
UMLS CUI [1]
C2348070
Specify start date of therapy:
Beschrijving

Start date

Datatype

date

Alias
UMLS CUI [1]
C0808070
Specify last date of therapy:
Beschrijving

End date

Datatype

date

Alias
UMLS CUI [1]
C0806020
Informed consent to participate in Concomitant studies and for storage of clinical samples
Beschrijving

Informed consent to participate in Concomitant studies and for storage of clinical samples

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0521115
UMLS CUI-3
C0008976
UMLS CUI-5
C0021430
UMLS CUI-6
C3242025
Early diagnosis of high risk patient for relapse?
Beschrijving

High risk for relapse

Datatype

boolean

Alias
UMLS CUI [1,1]
C0684030
UMLS CUI [1,2]
C0277556
Moleculargenetic evidence of minimal CNS leukemia?
Beschrijving

CNS leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C1332884
Diagnostic meaning of IL-15 in CNS-leukemia?
Beschrijving

IL-15 and CNS leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0254610
UMLS CUI [1,2]
C1332884
Genetic change in leukemic cells and its prognostic meaning?
Beschrijving

Genetic change in leukemic cells

Datatype

boolean

Alias
UMLS CUI [1,1]
C1517806
UMLS CUI [1,2]
C1705285
Genetic variation as risk factors for severe infections (during chemotherapy)?
Beschrijving

Genetic variation as risk factors for infections

Datatype

boolean

Alias
UMLS CUI [1,1]
C1705285
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0009450
Storage of clinical samples for future trials about leukemia?
Beschrijving

Storage of clinical samples: Leukemia trials

Datatype

boolean

Alias
UMLS CUI [1,1]
C3242025
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0023418
Storage of clinical samples for future trials about host cells -target?
Beschrijving

Storage of clinical samples: host cells -target- trials

Datatype

boolean

Alias
UMLS CUI [1,1]
C3242025
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1819995
UMLS CUI [1,4]
C1521840
Storage of clinical samples for future trials about host cells -whole genom?
Beschrijving

Storage of clinical samples: host cells -whole genom- trials

Datatype

boolean

Alias
UMLS CUI [1,1]
C3242025
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1819995
UMLS CUI [1,4]
C2350277
Laboratory Diagnostic
Beschrijving

Laboratory Diagnostic

Alias
UMLS CUI-1
C1254361
Immunologic tests
Beschrijving

Immunologic tests

Datatype

text

Alias
UMLS CUI [1]
C0021061
If immunologic tests were performed in not-referrence laboratory, specify:
Beschrijving

Immunologic tests: Specification

Datatype

text

Alias
UMLS CUI [1,1]
C0021061
UMLS CUI [1,2]
C2348235
Karyotypization and Moleculargenetics (RT-PCR, FISH for diagnosis of TEL/AML1, BCR/ABL, MLL-Rearrangements, others)
Beschrijving

Karyotypization and Moleculargenetics

Datatype

text

Alias
UMLS CUI [1]
C0022526
UMLS CUI [2]
C1948182
If Karyotypization and Moleculargenetics were performed, specify laboratory:
Beschrijving

Karyotypization and Moleculargenetics: Specification

Datatype

text

Alias
UMLS CUI [1,1]
C0022526
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C1948182
UMLS CUI [2,2]
C2348235
Identification and Signature
Beschrijving

Identification and Signature

Alias
UMLS CUI-1
C0205396
UMLS CUI-2
C1519316
Doctor's Name
Beschrijving

Doctor's Name

Datatype

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0031831
Date of report
Beschrijving

Date of report

Datatype

date

Alias
UMLS CUI [1]
C1302584
Doctor's signature
Beschrijving

Signature

Datatype

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Registry Formular AIEOP-BFM ALL 2009 NCT01117441

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient name
Item
Patient name
text
C1299487 (UMLS CUI [1])
Patient Birth Date
Item
Patient Birth Date
date
C0421451 (UMLS CUI [1])
Item
Patient's gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Patient's gender
CL Item
Male (Male)
CL Item
Female (Female)
Date of diagnosis
Item
Date of diagnosis
date
C2316983 (UMLS CUI [1])
Therapy start date
Item
Therapy start date (start of pre-phase)
date
C3173309 (UMLS CUI [1])
Item Group
Eligibility Criteria
C0013893 (UMLS CUI-1)
Diagnosis of primary ALL
Item
Diagnosis of primary ALL
boolean
C0023449 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
BCR/ABL-rearrangement or t(9;22)
Item
Exclusion of BCR/ABL-rearrangement or translocation t(9;22)?
boolean
C0004891 (UMLS CUI [1])
C3897138 (UMLS CUI [2])
Pregnancy or nursing
Item
Exclusion of pregnancy or nursing?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Participation status
Item
Does patient participate in another study trial? (Except for associated studies)
boolean
C2348568 (UMLS CUI [1])
Informed consent
Item
Informed consent given by person who has custody of child (if patient > 15 y/o, informed consent given by patient himself/ herself) to participate in study and data storage
boolean
C0021430 (UMLS CUI [1])
Steroid therapy and chemotherapy regimen
Item
Did patient receive steroids (longer than 2 weeks; dosage >= 1 mg/kg/d) or cytostatics 4 weeks before diagnosis?
boolean
C0149783 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Comorbidity affecting study protocol
Item
Does the patient has any comorbidity which is interferring with study protocol?
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Item Group
If Patient received steroid therapy (longer than 2 weeks; dosage >= 1 mg/kg/d) or cytostatics 4 weeks before diagnosis, specify:
C0149783 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
Steroid therapy and chemotherapy regimen: Specification
Item
Specify steroid therapy and chemotherapy regimen:
text
C0149783 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Daily Dose
Item
Specify received daily dose:
float
C2348070 (UMLS CUI [1])
Start date
Item
Specify start date of therapy:
date
C0808070 (UMLS CUI [1])
End date
Item
Specify last date of therapy:
date
C0806020 (UMLS CUI [1])
Item Group
Informed consent to participate in Concomitant studies and for storage of clinical samples
C0021430 (UMLS CUI-1)
C0521115 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C0021430 (UMLS CUI-5)
C3242025 (UMLS CUI-6)
High risk for relapse
Item
Early diagnosis of high risk patient for relapse?
boolean
C0684030 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
CNS leukemia
Item
Moleculargenetic evidence of minimal CNS leukemia?
boolean
C1332884 (UMLS CUI [1])
IL-15 and CNS leukemia
Item
Diagnostic meaning of IL-15 in CNS-leukemia?
boolean
C0254610 (UMLS CUI [1,1])
C1332884 (UMLS CUI [1,2])
Genetic change in leukemic cells
Item
Genetic change in leukemic cells and its prognostic meaning?
boolean
C1517806 (UMLS CUI [1,1])
C1705285 (UMLS CUI [1,2])
Genetic variation as risk factors for infections
Item
Genetic variation as risk factors for severe infections (during chemotherapy)?
boolean
C1705285 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
Storage of clinical samples: Leukemia trials
Item
Storage of clinical samples for future trials about leukemia?
boolean
C3242025 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0023418 (UMLS CUI [1,3])
Storage of clinical samples: host cells -target- trials
Item
Storage of clinical samples for future trials about host cells -target?
boolean
C3242025 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1819995 (UMLS CUI [1,3])
C1521840 (UMLS CUI [1,4])
Storage of clinical samples: host cells -whole genom- trials
Item
Storage of clinical samples for future trials about host cells -whole genom?
boolean
C3242025 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1819995 (UMLS CUI [1,3])
C2350277 (UMLS CUI [1,4])
Item Group
Laboratory Diagnostic
C1254361 (UMLS CUI-1)
Item
Immunologic tests
text
C0021061 (UMLS CUI [1])
Immunologic tests
Code List
Immunologic tests
CL Item
Not performed (Not performed)
CL Item
Performed: in referrence laboratory (Berlin-Buch, Prof. Ludwig) (Performed: in referrence laboratory (Berlin-Buch, Prof. Ludwig))
CL Item
Performed: not in referrence laboratory (Performed: not in referrence laboratory)
Immunologic tests: Specification
Item
If immunologic tests were performed in not-referrence laboratory, specify:
text
C0021061 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Karyotypization and Moleculargenetics (RT-PCR, FISH for diagnosis of TEL/AML1, BCR/ABL, MLL-Rearrangements, others)
text
C0022526 (UMLS CUI [1])
C1948182 (UMLS CUI [2])
Karyotypization and Moleculargenetics
Code List
Karyotypization and Moleculargenetics (RT-PCR, FISH for diagnosis of TEL/AML1, BCR/ABL, MLL-Rearrangements, others)
CL Item
Not performed (Not performed)
CL Item
Performed: in referrence laboratory (Performed: in referrence laboratory )
CL Item
Performed: not in referrence laboratory (Performed: not in referrence laboratory)
Karyotypization and Moleculargenetics: Specification
Item
If Karyotypization and Moleculargenetics were performed, specify laboratory:
text
C0022526 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1948182 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Identification and Signature
C0205396 (UMLS CUI-1)
C1519316 (UMLS CUI-2)
Doctor's Name
Item
Doctor's Name
text
C0027365 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Signature
Item
Doctor's signature
text
C1519316 (UMLS CUI [1])
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