0 Evaluaciones

ID

30122

Descripción

Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Palabras clave

  1. 13/5/18 13/5/18 -
  2. 14/5/18 14/5/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

13 de mayo de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

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    Oral GW786034 treatment for ovarian cancer NCT00281632

    Visit description: Treatment Period 1. Day 1

    Header
    Descripción

    Header

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descripción

    Subject Identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Descripción

    Visit Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Centre Number
    Descripción

    Centre Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Vital signs
    Descripción

    Vital signs

    Heart rate
    Descripción

    Heart rate

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Blood pressure, systolic
    Descripción

    Blood pressure, systolic

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Blood pressure, diastolic
    Descripción

    Blood pressure, diastolic

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Temperature
    Descripción

    Temperature

    Tipo de datos

    float

    Unidades de medida
    • ° C
    Alias
    UMLS CUI [1]
    C0039476
    ° C
    ECOG Performance Status
    Descripción

    ECOG Performance Status

    Alias
    UMLS CUI-1
    C1520224
    ECOG
    Descripción

    This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1520224
    Electronically transferred laboratory data - CA-125
    Descripción

    Electronically transferred laboratory data - CA-125

    Alias
    UMLS CUI-1
    C0200345
    UMLS CUI-3
    C0022885
    UMLS CUI-5
    C0201549
    Date sample taken
    Descripción

    Date sample taken CA-125

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0201549
    Physical examination
    Descripción

    Physical examination

    Alias
    UMLS CUI-1
    C0031809
    Has a physical examination been performed on the subject?
    Descripción

    physical examination

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0031809
    Examination Status
    Descripción

    Examination Status

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0449438
    If abnormal record below
    Descripción

    abnormal physical examination

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0459424
    Concomitant Medications
    Descripción

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Adverse Events
    Descripción

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Local Laboratory - Haematology
    Descripción

    Local Laboratory - Haematology

    Alias
    UMLS CUI-1
    C0474523
    UMLS CUI-2
    C0022885
    Lab ID
    Descripción

    Lab ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0600091
    Laboratory name
    Descripción

    Laboratory name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1882331
    Address
    Descripción

    Laboratory Address

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3262820
    Date Sample taken Haematology
    Descripción

    Date Sample taken Haematology

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0018941
    UMLS CUI [1,3]
    C1302413
    Haematocrit (HCT)
    Descripción

    Haematocrit (HCT)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0018935
    Haemoglobin (Hb)
    Descripción

    Haemoglobin (Hb)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0518015
    Platelet count (absolute)
    Descripción

    Platelet count (absolute)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0032181
    White blood cell count (WBC) (Absolute)
    Descripción

    White blood cell count (WBC) (Absolute)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0023508
    Neutrophil count (absolute)
    Descripción

    Neutrophil count (absolute)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0948762
    Lymphocyte count (absolute)
    Descripción

    Lymphocyte count (absolute)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C3544087
    Local Laboratory - Clinical Chemistry
    Descripción

    Local Laboratory - Clinical Chemistry

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C0022885
    Lab ID
    Descripción

    Lab ID

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0600091
    Laboratory name
    Descripción

    Laboratory name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1882331
    Address
    Descripción

    Laboratory Address

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3262820
    Date sample taken clinical chemistry
    Descripción

    Date sample taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C1302413
    Alkaline phosphatase
    Descripción

    Alkaline phosphatase

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201850
    ALT (SGPT)
    Descripción

    ALT (SGPT)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201836
    AST (SGOT)
    Descripción

    AST (SGOT)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201899
    Albumin
    Descripción

    Albumin

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201838
    Total bilirubin
    Descripción

    Total bilirubin

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201913
    Blood Urea Nitrogen
    Descripción

    BUN

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005845
    Calcium
    Descripción

    Calcium

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201925
    Serum Creatinine
    Descripción

    Serum Creatinine

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201976
    Glucose (fasting)
    Descripción

    Glucose (fasting)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0583513
    LDH
    Descripción

    LDH

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0202113
    Potassium
    Descripción

    Potassium

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0202194
    Sodium
    Descripción

    Sodium

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0337443
    Urinalysis
    Descripción

    Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Date sample taken
    Descripción

    Date sample taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413
    Laboratory name
    Descripción

    Laboratory name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3258037
    Address
    Descripción

    Address

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1442065
    UMLS CUI [1,2]
    C0022877
    UPC ratio
    Descripción

    UPC ratio

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C1524119
    UMLS CUI [1,2]
    C0033684
    UMLS CUI [1,3]
    C1522609
    Lab ID
    Descripción

    Lab ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0600091
    Tumour Tissue Sample Collection
    Descripción

    Tumour Tissue Sample Collection

    Alias
    UMLS CUI-1
    C0475358
    UMLS CUI-2
    C0005558
    Has a tissue sample been collected?
    Descripción

    tumor tissue collection

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C0005558
    If No, tick appropriate reason
    Descripción

    no biopsy reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C1272696
    UMLS CUI [1,3]
    C0392360
    If other, please specify
    Descripción

    Other

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0205394
    Sample Collection
    Descripción

    Sample Collection

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1547864
    Preservation Method
    Descripción

    Biopsy sample preservation method

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C1514402
    Form Type
    Descripción

    tissue sample form type

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C0332479
    Type of Tissue Biopsy
    Descripción

    Type of Tissue Biopsy

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C0005558
    UMLS CUI [1,3]
    C0332307
    Organ Code
    Descripción

    Organ code

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0678852
    UMLS CUI [1,2]
    C0805701
    Tissue Source
    Descripción

    Tissue Source

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C0449416
    UMLS CUI [1,3]
    C0678257
    Date Biopsy Taken
    Descripción

    Date Biopsy Taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C1302413
    Time Biopsy Taken
    Descripción

    Time Biopsy Taken

    Tipo de datos

    partialDatetime

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0040223
    Consent for tumour genetic research
    Descripción

    Consent for tumour genetic research

    Alias
    UMLS CUI-1
    C0586888
    UMLS CUI-2
    C0243064
    Has consent been obtained for tumour genetic research?
    Descripción

    consent for tumour genetic research

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0243064
    If yes, record date consent obtained
    Descripción

    date of informed consent

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985782
    If no, tick one reason
    Descripción

    reason no consent given

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C1705492
    if other, specify
    Descripción

    other reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3840932
    Withdrawal of consent
    Descripción

    Withdrawal of consent

    Has subject withdrawn consent for tumour genetic research?
    Descripción

    Withdrawal of consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C0243064
    If Yes, record the date informed consent withdrawn for tumour genetic research
    Descripción

    Date of withdrawal of consent

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1707492
    UMLS CUI [1,3]
    C0243064
    Sample Destruction
    Descripción

    Sample Destruction

    Alias
    UMLS CUI-1
    C1948029
    UMLS CUI-2
    C0475358
    Has a request been made for tumour genetics tissue sample destruction?
    Descripción

    Request made for destruction of tumour sample

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    If yes, tick one reason
    Descripción

    Reason for tumour sample destruction

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0475358
    If other, please specify
    Descripción

    Other

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0205394
    Biomarker sample(s)
    Descripción

    Biomarker sample(s)

    Alias
    UMLS CUI-1
    C0005516
    Sample Type
    Descripción

    Biomarker Sample Type

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347029
    UMLS CUI [1,2]
    C0005516
    Has sample been collected?
    Descripción

    Biomarker sample collected

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0005516
    UMLS CUI [1,2]
    C0200345
    If No, provide reason
    Descripción

    If no, reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0681841
    Date sample taken
    Descripción

    Date sample taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413
    Time sample taken
    Descripción

    Time sample taken

    Tipo de datos

    partialDatetime

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345

    Similar models

    Visit description: Treatment Period 1. Day 1

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Header
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Item Group
    Vital signs
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Blood pressure, systolic
    Item
    Blood pressure, systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood pressure, diastolic
    Item
    Blood pressure, diastolic
    integer
    C0428883 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0039476 (UMLS CUI [1])
    Item Group
    ECOG Performance Status
    C1520224 (UMLS CUI-1)
    ECOG
    Item
    ECOG
    integer
    C1520224 (UMLS CUI [1])
    Item Group
    Electronically transferred laboratory data - CA-125
    C0200345 (UMLS CUI-1)
    C0022885 (UMLS CUI-3)
    C0201549 (UMLS CUI-5)
    Date sample taken CA-125
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0201549 (UMLS CUI [1,2])
    Item Group
    Physical examination
    C0031809 (UMLS CUI-1)
    physical examination
    Item
    Has a physical examination been performed on the subject?
    boolean
    C0031809 (UMLS CUI [1])
    Item
    Examination Status
    integer
    C0031809 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Code List
    Examination Status
    CL Item
    Normal (N)
    (Comment:en)
    CL Item
    Abnormal (please specify) (A)
    (Comment:en)
    abnormal physical examination
    Item
    If abnormal record below
    text
    C0031809 (UMLS CUI [1,1])
    C0459424 (UMLS CUI [1,2])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Item Group
    Adverse Events
    C0877248 (UMLS CUI-1)
    Item Group
    Local Laboratory - Haematology
    C0474523 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    Lab ID
    Item
    Lab ID
    text
    C0022877 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Laboratory name
    Item
    Laboratory name
    text
    C1882331 (UMLS CUI [1])
    Laboratory Address
    Item
    Address
    text
    C3262820 (UMLS CUI [1])
    Date Sample taken Haematology
    Item
    Date Sample taken Haematology
    date
    C0005834 (UMLS CUI [1,1])
    C0018941 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Haematocrit (HCT)
    Item
    Haematocrit (HCT)
    float
    C0018935 (UMLS CUI [1])
    Haemoglobin (Hb)
    Item
    Haemoglobin (Hb)
    float
    C0518015 (UMLS CUI [1])
    Platelet count (absolute)
    Item
    Platelet count (absolute)
    float
    C0032181 (UMLS CUI [1])
    White blood cell count (WBC) (Absolute)
    Item
    White blood cell count (WBC) (Absolute)
    float
    C0023508 (UMLS CUI [1])
    Neutrophil count (absolute)
    Item
    Neutrophil count (absolute)
    float
    C0948762 (UMLS CUI [1])
    Lymphocyte count (absolute)
    Item
    Lymphocyte count (absolute)
    float
    C3544087 (UMLS CUI [1])
    Item Group
    Local Laboratory - Clinical Chemistry
    C0008000 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    Lab ID
    Item
    Lab ID
    integer
    C0022877 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Laboratory name
    Item
    Laboratory name
    text
    C1882331 (UMLS CUI [1])
    Laboratory Address
    Item
    Address
    text
    C3262820 (UMLS CUI [1])
    Date sample taken
    Item
    Date sample taken clinical chemistry
    date
    C0005834 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Alkaline phosphatase
    Item
    Alkaline phosphatase
    float
    C0201850 (UMLS CUI [1])
    ALT (SGPT)
    Item
    ALT (SGPT)
    float
    C0201836 (UMLS CUI [1])
    AST (SGOT)
    Item
    AST (SGOT)
    float
    C0201899 (UMLS CUI [1])
    Albumin
    Item
    Albumin
    float
    C0201838 (UMLS CUI [1])
    Total bilirubin
    Item
    Total bilirubin
    float
    C0201913 (UMLS CUI [1])
    BUN
    Item
    Blood Urea Nitrogen
    float
    C0005845 (UMLS CUI [1])
    Calcium
    Item
    Calcium
    float
    C0201925 (UMLS CUI [1])
    Serum Creatinine
    Item
    Serum Creatinine
    float
    C0201976 (UMLS CUI [1])
    Glucose (fasting)
    Item
    Glucose (fasting)
    float
    C0583513 (UMLS CUI [1])
    LDH
    Item
    LDH
    float
    C0202113 (UMLS CUI [1])
    Potassium
    Item
    Potassium
    float
    C0202194 (UMLS CUI [1])
    Sodium
    Item
    Sodium
    float
    C0337443 (UMLS CUI [1])
    Item Group
    Urinalysis
    C0042014 (UMLS CUI-1)
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Laboratory name
    Item
    Laboratory name
    text
    C3258037 (UMLS CUI [1])
    Address
    Item
    Address
    text
    C1442065 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    UPC ratio
    Item
    UPC ratio
    float
    C1524119 (UMLS CUI [1,1])
    C0033684 (UMLS CUI [1,2])
    C1522609 (UMLS CUI [1,3])
    Lab ID
    Item
    Lab ID
    text
    C0022877 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item Group
    Tumour Tissue Sample Collection
    C0475358 (UMLS CUI-1)
    C0005558 (UMLS CUI-2)
    tumor tissue collection
    Item
    Has a tissue sample been collected?
    boolean
    C0475358 (UMLS CUI [1,1])
    C0005558 (UMLS CUI [1,2])
    Item
    If No, tick appropriate reason
    text
    C0005558 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Code List
    If No, tick appropriate reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (OT)
    Other
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1])
    Item
    Sample Collection
    text
    C1547864 (UMLS CUI [1])
    Code List
    Sample Collection
    CL Item
    Derived During Study (1)
    CL Item
    Archieved (2)
    Item
    Preservation Method
    text
    C0475358 (UMLS CUI [1,1])
    C1514402 (UMLS CUI [1,2])
    Code List
    Preservation Method
    CL Item
    FFPE (1)
    CL Item
    Fresh-frozen (2)
    Item
    Form Type
    text
    C0475358 (UMLS CUI [1,1])
    C0332479 (UMLS CUI [1,2])
    Code List
    Form Type
    CL Item
    Block (1)
    CL Item
    Slides (2)
    Item
    Type of Tissue Biopsy
    text
    C0475358 (UMLS CUI [1,1])
    C0005558 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    Code List
    Type of Tissue Biopsy
    CL Item
    Core (1)
    CL Item
    Excisional (2)
    CL Item
    FNA (fine needle aspiration) (3)
    CL Item
    Punch (4)
    CL Item
    Other, specify (OT)
    Item
    Organ Code
    text
    C0678852 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Code List
    Organ Code
    CL Item
    Abdomen/abdominal wall  (AB)
    CL Item
    Liver  (LV)
    CL Item
    Lymph nodes  (LN)
    CL Item
    Ovary  (OV)
    CL Item
    Peritoneum (PM)
    CL Item
    Spleen (SP)
    CL Item
    Small intestine (SI)
    CL Item
    Other, specify (CT)
    Item
    Tissue Source
    text
    C0475358 (UMLS CUI [1,1])
    C0449416 (UMLS CUI [1,2])
    C0678257 (UMLS CUI [1,3])
    Code List
    Tissue Source
    CL Item
    Primary (1)
    CL Item
    Metastasic (2)
    CL Item
    Unknown (U)
    Date Biopsy Taken
    Item
    Date Biopsy Taken
    date
    C0005558 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Time Biopsy Taken
    Item
    Time Biopsy Taken
    partialDatetime
    C0005558 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item Group
    Consent for tumour genetic research
    C0586888 (UMLS CUI-1)
    C0243064 (UMLS CUI-2)
    consent for tumour genetic research
    Item
    Has consent been obtained for tumour genetic research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C0243064 (UMLS CUI [1,2])
    date of informed consent
    Item
    If yes, record date consent obtained
    date
    C2985782 (UMLS CUI [1])
    Item
    If no, tick one reason
    text
    C0566251 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C1705492 (UMLS CUI [1,3])
    Code List
    If no, tick one reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (3)
    other reason
    Item
    if other, specify
    text
    C3840932 (UMLS CUI [1])
    Item Group
    Withdrawal of consent
    Withdrawal of consent
    Item
    Has subject withdrawn consent for tumour genetic research?
    boolean
    C1707492 (UMLS CUI [1,1])
    C0243064 (UMLS CUI [1,2])
    Date of withdrawal of consent
    Item
    If Yes, record the date informed consent withdrawn for tumour genetic research
    date
    C0011008 (UMLS CUI [1,1])
    C1707492 (UMLS CUI [1,2])
    C0243064 (UMLS CUI [1,3])
    Item Group
    Sample Destruction
    C1948029 (UMLS CUI-1)
    C0475358 (UMLS CUI-2)
    Request made for destruction of tumour sample
    Item
    Has a request been made for tumour genetics tissue sample destruction?
    boolean
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    Item
    If yes, tick one reason
    text
    C0392360 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0475358 (UMLS CUI [1,3])
    Code List
    If yes, tick one reason
    CL Item
    Subject withdrew consent for tumour genetic research (4)
    CL Item
    Other, specify (OT)
    Other
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1])
    Item Group
    Biomarker sample(s)
    C0005516 (UMLS CUI-1)
    Item
    Sample Type
    text
    C2347029 (UMLS CUI [1,1])
    C0005516 (UMLS CUI [1,2])
    Code List
    Sample Type
    CL Item
    Platelet poor plasma  (1)
    CL Item
    Serum  (2)
    CL Item
    Bone marrow aspirate  (3)
    CL Item
    Whole blood  (5)
    CL Item
    Urine  (6)
    CL Item
    Mucus  (7)
    CL Item
    Plasma (8)
    CL Item
    Saliva (9)
    CL Item
    Stool (10)
    CL Item
    Ascites (11)
    CL Item
    Cerebral spinal fluid (12)
    CL Item
    Pleural fluid (13)
    CL Item
    Buccal swab (15)
    Biomarker sample collected
    Item
    Has sample been collected?
    boolean
    C0005516 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    If No, provide reason
    text
    C0681841 (UMLS CUI [1])
    Code List
    If No, provide reason
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (OT)
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Time sample taken
    Item
    Time sample taken
    partialDatetime
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])

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