ID

15077

Beskrivning

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Initial survey. Please send this document within one month after diagnosis to the study centre. Clinical Trial Number: NCT01117441.

Nyckelord

Pädiatrie

Clinical Trial

ALL

Anamnesenerhebung

2016-05-15 2016-05-15 -

Uppladdad den

15 maj 2016

DOI

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Licens

Creative Commons BY-NC-ND 3.0

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Initial survey AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

model
Detaljer

Initial survey AIEOP-BFM ALL 2009 NCT01117441

1 Formulär

StudyEvent: ODM
1. Initial survey AIEOP-BFM ALL 2009 NCT01117441

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Patient Information

Item Group

Patient Information

C1955348 (UMLS CUI-1)

Patient Study ID

Item

Patient Study ID

text

C2348585 (UMLS CUI [1])

Patient date of birth

Item

Patient date of birth

date

C0421451 (UMLS CUI [1])

Informed consent

Item

Informed consent

text

C0021430 (UMLS CUI [1])

Anamnesis

Item Group

Anamnesis

C0199182 (UMLS CUI-1)

Hospital stay

Item

Hospital stay during the last four weeks before diagnosis

boolean

C3489408 (UMLS CUI [1])

Hospital stay: Hospital

Item

Hospital stay: If "Yes", specify hospital:

text

C3489408 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])

Hospital stay: Date of hospitalisation

Item

Hospital stay: If "Yes", specify date of hospitalisation:

date

C3489408 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Hospital stay: Date of discharge

Item

Hospital stay: If "Yes", specify date of discharge:

date

C3489408 (UMLS CUI [1,1])
C2361123 (UMLS CUI [1,2])

Birth weight

Item

Birth weight

float

C0005612 (UMLS CUI [1])

Birth size

Item

Birth size

text

C0005901 (UMLS CUI [1,1])
C2599577 (UMLS CUI [1,2])

Gestational age

Item

Gestational age

text

C0017504 (UMLS CUI [1])

Medical assisted reproduction

Item

Medical assisted reproduction

boolean

C0493980 (UMLS CUI [1])

Number of siblings

Item

Number of siblings

float

C0037047 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Number of half siblings

Item

Number of half siblings

float

C0237753 (UMLS CUI [1,1])
C0337505 (UMLS CUI [1,2])

Number of not biological siblings

Item

Number of not biological siblings

float

C0337502 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])

Multiple birth offspring

Item

Multiple birth offspring

text

C0026753 (UMLS CUI [1])

Multiple birth offspring

Code List

Multiple birth offspring

CL Item

no (no)

CL Item

yes, twins (yes, twins)

CL Item

yes, multiples (yes, multiples)

Multiple birth offspring: zygosity

Item

Multiple birth offspring If "Yes", specify zygosity:

text

C0026753 (UMLS CUI [1,1])
C1710709 (UMLS CUI [1,2])

Multiple birth offspring: zygosity

Code List

Multiple birth offspring If "Yes", specify zygosity:

CL Item

dizygotic (dizygotic)

CL Item

monozygotic (monozygotic)

Fever

Item

Fever > 38,5 °C

boolean

C0015967 (UMLS CUI [1])

Pathogen detection

Item

Pathogen detection

boolean

C1740302 (UMLS CUI [1])

Pathogen detection: specification

Item

Pathogen detection If "Yes", specify:

text

C1740302 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

CRP increase

Item

CRP increase

boolean

C0201657 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])

CRP measurement

Item

CRP measurement: If a positive CRP increase, specify:

float

C0201657 (UMLS CUI [1])

Malignancies

Item

Previous disease: Malignancies

boolean

C0006826 (UMLS CUI [1])

Malignancies: specification

Item

Previous disease: Malignancies: If "Yes", specify:

text

C0006826 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Immune deficiency

Item

Previous disease: Immune deficiency

boolean

C1855771 (UMLS CUI [1])

Immune deficiency: specification

Item

Previous disease: Immune deficiency If "Yes", specify:

text

C1855771 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Haematological disease

Item

Previous disease: Haematological disease

boolean

C0018939 (UMLS CUI [1])

Haematological disease: specification

Item

Previous disease: Haematological disease If "Yes", specify:

text

C0018939 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Chronic virus infection

Item

Previous disease: Chronic virus infection

boolean

C3829806 (UMLS CUI [1,1])
C0042769 (UMLS CUI [1,2])

Chronic virus infection: specification

Item

Previous disease: Chronic virus infection If "Yes", specify:

text

C3829806 (UMLS CUI [1,1])
C0042769 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Chromosomal aberration/ hereditary disease

Item

Previous disease: Chromosomal aberration/ hereditary disease

boolean

C0008625 (UMLS CUI [1])
C0019247 (UMLS CUI [2])

Chromosomal aberration/ hereditary disease: specification

Item

Previous disease: Chromosomal aberration/ hereditary disease If "Yes", specify:

text

C0008625 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0019247 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])

Metabolic disease

Item

Previous disease: Metabolic disease

boolean

C0025517 (UMLS CUI [1])

Metabolic disease: specification

Item

Previous disease: Metabolic disease If "Yes", specify:

text

C0025517 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Autoimmune disease

Item

Previous disease: Autoimmune disease

boolean

C0004364 (UMLS CUI [1])

Autoimmune disease: specification

Item

Previous disease: Autoimmune disease If "Yes", specify:

text

C0004364 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Cardiac disease

Item

Previous disease: Cardiac disease

boolean

C0018799 (UMLS CUI [1])

Cardiac disease: specification

Item

Previous disease: Cardiac disease If "Yes", specify:

text

C0018799 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Chronic disease

Item

Previous disease: Chronic disease

boolean

C0008679 (UMLS CUI [1])

Chronic disease: specification

Item

Previous disease: Chronic disease If "Yes", specify:

text

C0008679 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Siblings suffering from malignancy

Item

Siblings suffering from malignancy

boolean

C0337502 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])

Siblings suffering from malignancy specification

Item

Siblings suffering from malignancy If "Yes", specify:

text

C0337502 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Mother suffering from malignancy

Item

Mother suffering from malignancy

boolean

C0026591 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])

Mother suffering from malignancy specification

Item

Mother suffering from malignancy If "Yes", specify:

text

C0026591 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Parents of mother suffering from malignancy

Item

Parents of mother suffering from malignancy

text

C0337471 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])

Parents of mother suffering from malignancy

Code List

Parents of mother suffering from malignancy

CL Item

no (no)

CL Item

yes, mother's mother (yes, mother's mother)

CL Item

yes, mother's father (yes, mother's father)

Mother of mother suffering from malignancy

Item

Mother of mother suffering from malignancy If "Yes, mother's mother", specify:

text

C0337474 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Father of mother suffering from malignancy

Item

Father of mother suffering from malignancy If "Yes, mother's father", specify:

text

C0337475 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Siblings of mother suffering from malignancy

Item

Siblings of mother suffering from malignancy

boolean

C0037047 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])

Siblings of mother suffering from malignancy specification

Item

Siblings of mother suffering from malignancy: If "Yes", specify:

text

C0037047 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Niece/nephew of mother suffering from malignancy

Item

Niece/nephew of mother suffering from malignancy

boolean

C1553703 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])

Niece/nephew of mother suffering from malignancy specification

Item

Niece/nephew of mother suffering from malignancy specification If "Yes", specify:

text

C1553703 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Father suffering from malignancy

Item

Father suffering from malignancy

boolean

C0015671 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])

Father suffering from malignancy specification

Item

Father suffering from malignancy If "Yes", specify:

text

C0015671 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Parents of father suffering from malignancy

Item

Parents of father suffering from malignancy

text

C0337471 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])

Parents of father suffering from malignancy

Code List

Parents of father suffering from malignancy

CL Item

no (no)

CL Item

yes, father's mother (yes, father's mother)

CL Item

yes, father's father (yes, fathers father)

Mother of father suffering from malignancy

Item

Mother of father suffering from malignancy If "Yes, father's mother", specify:

text

C0337474 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Father of father suffering from malignancy

Item

Father of father suffering from malignancy If "Yes, father's father", specify:

text

C0337475 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Siblings of father suffering from malignancy

Item

Siblings of father suffering from malignancy

boolean

C0037047 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])

Siblings of mother suffering from malignancy

Item

Siblings of mother suffering from malignancy

text

C0037047 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Niece/nephew of father suffering from malignancy

Item

Niece/nephew of father suffering from malignancy

boolean

C1553703 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])

Niece/nephew of father suffering from malignancy

Item

Niece/nephew of father suffering from malignancy If "Yes", specify:

text

C1553703 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Diagnosis

Item Group

Diagnosis

C0011900 (UMLS CUI-1)

Hospital admission date

Item

Hospital admission date (in hospital of study centre)

date

C0806429 (UMLS CUI [1])

Leukopheresis

Item

Leukopheresis performed?

boolean

C0023416 (UMLS CUI [1])

Leukopheresis start date

Item

Leukopheresis: If "Yes", specify start date:

date

C0023416 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Leukopheresis end date

Item

Leukopheresis: If "Yes", specify end date:

date

C0023416 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Weight

Item

Weight

float

C0005910 (UMLS CUI [1])

Height

Item

Height

float

C0005890 (UMLS CUI [1])

Blood analysis

Item Group

Blood analysis

C0018941 (UMLS CUI-1)

Initial blood analysis: date

Item

Date of initial blood analysis (first hospital admission, before transfusion)

date

C0011008 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])

Initial blood analysis: leukocytes

Item

Initial blood analysis: leukocytes

float

C0023508 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])

Inital blood analysis: blasts

Item

Inital blood analysis: blasts

float

C0523113 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])

Initial blood analysis: platelets

Item

Initial blood analysis: platelets

float

C0032181 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])

Initial blood analysis: haemoglobin

Item

Initial blood analysis: haemoglobin

float

C0518015 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])

Blood analysis at diagnosis: date

Item

Date of blood analysis at diagnosis (usually at bone-marrow-puncture; if there was no BMP perfomed before therapy start, take blood analysis wich was relevant for diagnosis)

date

C0011008 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])

Blood analysis at diagnosis: leukocytes

Item

Blood analysis at diagnosis: leukocytes

float

C0023508 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])

Blood analysis at diagnosis: blasts

Item

Blood analysis at diagnosis: blasts

float

C0523113 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])

Blood analysis at therapy start: date

Item

Date of blood analysis at therapy start (Day 1 of the pre phase)

date

C0011008 (UMLS CUI [1,1])
C2114713 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])

Blood analysis at therapy start: leukocytes

Item

Blood analysis at therapy start: leukocytes

float

C0023508 (UMLS CUI [1,1])
C2114713 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])

Blood analysis at therapy start: blasts

Item

Blood analysis at therapy start: blasts

float

C0523113 (UMLS CUI [1,1])
C2114713 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])

Initial CNS status

Item Group

Initial CNS status

C0449389 (UMLS CUI-1)
C0205265 (UMLS CUI-2)

Initial lumbar puncture: date

Item

Initial lumbar puncture: date

date

C2584899 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0553794 (UMLS CUI [1,3])

Cerebrospinal fluid contaminated with blood

Item

Cerebrospinal fluid contaminated with blood (macroscopically)

boolean

C0007806 (UMLS CUI [1,1])
C2349974 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])

Cerebrospinal fluid: cell count

Item

Cerebrospinal fluid: Cell count performed? (with haemocytometer)

boolean

C1317024 (UMLS CUI [1])

Cerebrospinal fluid: erythrocytes

Item

Cerebrospinal fluid: If cell count performed, specify erythrocytes:

float

C2026591 (UMLS CUI [1])

Cerebrospinal fluid: nucleated cells

Item

Cerebrospinal fluid: If cell count performed, specify nucleated cells:

float

C2926229 (UMLS CUI [1])

Cytomorphological assessment of cytospin compound

Item

Cytomorphological assessment of cytospin

text

C1271796 (UMLS CUI [1,1])
C0543482 (UMLS CUI [1,2])
C0010819 (UMLS CUI [1,3])

Cytomorphological assessment of cytospin

Code List

Cytomorphological assessment of cytospin

CL Item

performed: assessment in study centre (performed: assessment in study centre)

CL Item

performed: assessment locally only (please add all results) (performed: assessment locally only (please add all results))

CL Item

not performed: no cytospin compounds prepared (not performed: no cytospin compounds prepared)

CL Item

not performed: cytospin compounds not evaluable (not performed: cytospin compounds not evaluable)

Blasts in cytospin compound

Item

Cytomorphological blasts in cytospin compound?

boolean

C0523113 (UMLS CUI [1,1])
C1271796 (UMLS CUI [1,2])

Initial diagnostic imaging of CNS

Item

Initial diagnostic imaging of CNS

text

C0011923 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])

Initial diagnostic imaging of CNS

Code List

Initial diagnostic imaging of CNS

CL Item

performed: MRI (performed: MRI)

CL Item

performed: CT (performed: CT)

CL Item

not performed (not performed)

Initial diagnostic imaging of CNS: Date

Item

Initial diagnostic imaging of CNS If performed, specify date of procedure:

date

C2584899 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C3714787 (UMLS CUI [1,4])

Cerebral mass or leptomeningeal involvement

Item

Cerebral mass or leptomeningeal involvement found in imaging

text

C0742078 (UMLS CUI [1])
C3160796 (UMLS CUI [2])

Cerebral mass or leptomeningeal involvement

Code List

Cerebral mass or leptomeningeal involvement found in imaging

CL Item

yes (please add results and images on CD-ROM) (yes (please add results and images on CD-ROM))

CL Item

no (no)

Examination of cranial nerves

Item

Examination of cranial nerves: cranial nerves dysfunction?

text

C0558819 (UMLS CUI [1])

Examination of cranial nerves

Code List

Examination of cranial nerves: cranial nerves dysfunction?

CL Item

Yes (Yes)

CL Item

No (No)

CL Item

Examination of cranial nerves not performed (Examination of cranial nerves not performed)

Date of examination of cranial nerves

Item

Examination of cranial nerves: If performed, specify date:

date

C2826643 (UMLS CUI [1,1])
C0558819 (UMLS CUI [1,2])

Treatment of CNS

Item

Treatment of CNS

text

C0087111 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])

Treatment of CNS

Code List

Treatment of CNS

CL Item

Like "CNS negative" (Like "CNS negative")

CL Item

Like "CNS negative" and additional MTX (i.th.) in protocol IA (Like "CNS negative" and additional MTX (i.th.) in protocol IA)

CL Item

Like "CNS positive" (Like "CNS positive")

Multi-organ involvement

Item Group

Multi-organ involvement

C0457577 (UMLS CUI-1)

Liver size

Item

Liver size (palpatoric): performed?

boolean

C0426688 (UMLS CUI [1])

Liver size value

Item

Liver size (palpatoric) If performed, specify value: (in cm under costal arch in MCL)

float

C0426688 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])

Spleen size

Item

Spleen size (palpatoric): performed?

boolean

C0030250 (UMLS CUI [1])

Spleen size value

Item

Spleen size (palpatoric) If performed, specify value: (in cm under costal arch in MCL)

float

C0030250 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])

Involvement of mediastinum

Item

Involvement of mediastinum

text

C0025066 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])

Involvement of mediastinum

Code List

Involvement of mediastinum

CL Item

Yes (Yes)

CL Item

No (No)

CL Item

No examination performed (No examination performed)

Involvement of testicles

Item

Involvement of testicles

text

C0039597 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])

Involvement of testicles

Code List

Involvement of testicles

CL Item

Yes (Yes)

CL Item

No (No )

CL Item

No examinatin performed (No examinatin performed)

Prednisone response

Item Group

Prednisone response (on day 8 of cytoreductive pre-phase)

C0032952 (UMLS CUI-1)
C0871261 (UMLS CUI-2)

Date

Item

Date (on day 8 of cytoreductive pre-phase)

date

C0011008 (UMLS CUI [1])

Leukocytes

Item

Leukocytes

float

C0023508 (UMLS CUI [1])

Blasts

Item

Blasts (peripher)

float

C0523113 (UMLS CUI [1])

Cumulative dose of prednisone

Item

Cumulative dose of prednisone (7 days)

float

C0032952 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])

Comments

Item Group

Comments

C0947611 (UMLS CUI-1)

Comments

Item

Comments

text

C0947611 (UMLS CUI [1])

Identification and Signature

Item Group

Identification and Signature

C0205396 (UMLS CUI-1)
C1519316 (UMLS CUI-3)

Investigator's name

Item

Investigator's name

text

C2346576 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])

Date of report

Item

Date of report

date

C1302584 (UMLS CUI [1])

Investigator's signature

Item

Investigator's signature

text

C2346576 (UMLS CUI [1])

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Initial survey AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

Initial survey AIEOP-BFM ALL 2009 NCT01117441

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