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ID

27577

Description

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Progress Hinweis: Bis Visit 10 (nach letztem Zyklus der Chemotherapie) bedeutet die Feststellung eines Progresses: Abbruch der Studientherapie: AS – Bogen ausfüllen Bei klinischem Tumorprogress (vor der OP - bis Woche 12) ist für diesen Patienten der Abbruch der Studientherapie zu beschließen. Patienten, die im Behandlungsarm B therapiert werden, soll die HIPEC ohne zytoreduktive Chirurgie (nach Ausschluss von Kontraindikationen) durchgeführt werden. Die Weiterbehandlung erfolgt nach Ermessen des behandelnden Arztes.

Keywords

Versions (1)
  1. 11/20/17 11/20/17 -
Copyright Holder

Beate Rau

Uploaded on

November 20, 2017

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License

Creative Commons BY-NC 3.0
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    Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC)

    German

    Progress

    1 forms  
    1. StudyEvent: ODM
      1. Progress
    Administrative Documentation
    Description

    Administrative Documentation

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Zentrum-ID
    Description

    Center Identification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Patienten-ID
    Description

    Patient Identification

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Geburtsjahr
    Description

    Year of birth

    Data type

    partialDate

    Alias
    UMLS CUI [1]
    C2826771 (Birth Year)
    Follow up Nr.: (ergänzen Sie hier die fortlaufende Nummer: 02, 03, 04 usw.)
    Description

    Number of Follow up

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704685 (Follow-Up Report)
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Progress
    Description

    Progress

    Alias
    UMLS CUI-1
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    UMLS CUI-2
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    Progress festgestellt am (keine SAE-Meldung)
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    UMLS CUI [1,3]
    C1511790 (Detection)
    Progress nachgewiesen mit
    Description

    Diagnostic procedure

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430022 (diagnostic procedure)
    SNOMED
    103693007
    UMLS CUI [1,2]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    Lokalisation des Progresses
    Description

    Localization

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0475264 (localization)
    SNOMED
    257880008
    UMLS CUI [1,2]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    Metastasen
    Description

    Metastasis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    Metastasen, wenn ja
    Description

    Localization of metastases

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0475264 (localization)
    SNOMED
    257880008
    UMLS CUI [1,2]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    Andere Metastasen
    Description

    Other metastases

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Therapie des Progresses
    Description

    Progress therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    Therapie des Progresses
    Description

    Progress therapy

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    andere Therapie des Progresses
    Description

    Other progress therapy

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    UMLS CUI [1,3]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Administrative Dokumentation
    Description

    Administrative Dokumentation

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    CRF-Inhalt bestätigt am:
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Name (Druckbuchstaben)
    Description

    Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027365 (Name)
    SNOMED
    703503000
    LOINC
    LP72974-6
    Unterschrift
    Description

    Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519316 (Signature)
    LOINC
    LP248948-4
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    Similar models

    Progress

    1 forms
    1. StudyEvent: ODM
      1. Progress
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Documentation
    C1320722 (UMLS CUI-1)
    Center Identification
    Item
    Zentrum-ID
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Identification
    Item
    Patienten-ID
    integer
    C2348585 (UMLS CUI [1])
    Year of birth
    Item
    Geburtsjahr
    partialDate
    C2826771 (UMLS CUI [1])
    Number of Follow up
    Item
    Follow up Nr.: (ergänzen Sie hier die fortlaufende Nummer: 02, 03, 04 usw.)
    integer
    C1704685 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item Group
    Progress
    C0242656 (UMLS CUI-1)
    C0006826 (UMLS CUI-2)
    Date
    Item
    Progress festgestellt am (keine SAE-Meldung)
    date
    C0011008 (UMLS CUI [1,1])
    C0242656 (UMLS CUI [1,2])
    C1511790 (UMLS CUI [1,3])
    Item
    Progress nachgewiesen mit
    text
    C0430022 (UMLS CUI [1,1])
    C0242656 (UMLS CUI [1,2])
    Diagnostic procedure
    Code List
    Progress nachgewiesen mit
    CL Item
    Histologie (Histologie)
    CL Item
    Laparoskopie (Laparoskopie)
    CL Item
    Laparotomie (Laparotomie)
    CL Item
    Progredienter Aszites mit positiver Zytologie (Progredienter Aszites mit positiver Zytologie)
    CL Item
    MRT (MRT)
    CL Item
    PET (PET)
    CL Item
    CT (CT)
    CL Item
    Sonographie (Sonographie)
    CL Item
    Tumormarker CEA und/oder CA 72-4 (Tumormarker CEA und/oder CA 72-4)
    CL Item
    klinische Symptome (klinische Symptome)
    Item
    Lokalisation des Progresses
    text
    C0475264 (UMLS CUI [1,1])
    C0242656 (UMLS CUI [1,2])
    Localization
    Code List
    Lokalisation des Progresses
    CL Item
    abdominal (abdominal)
    CL Item
    extraabdominal (extraabdominal)
    Metastasis
    Item
    Metastasen
    boolean
    C0027627 (UMLS CUI [1])
    Item
    Metastasen, wenn ja
    text
    C0475264 (UMLS CUI [1,1])
    C0027627 (UMLS CUI [1,2])
    Localization of metastases
    Code List
    Metastasen, wenn ja
    CL Item
    Peritoneum (Peritoneum)
    CL Item
    Leber (Leber)
    CL Item
    Lunge (Lunge)
    CL Item
    Knochen (Knochen)
    CL Item
    ZNS (ZNS)
    CL Item
    Andere (Andere)
    Other metastases
    Item
    Andere Metastasen
    text
    C0027627 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Progress therapy
    Item
    Therapie des Progresses
    boolean
    C0087111 (UMLS CUI [1,1])
    C0242656 (UMLS CUI [1,2])
    Item
    Therapie des Progresses
    text
    C0087111 (UMLS CUI [1,1])
    C0242656 (UMLS CUI [1,2])
    Progress therapy
    Code List
    Therapie des Progresses
    CL Item
    Operation (SInt-Bogen ausfüllen) (Operation (SInt-Bogen ausfüllen))
    CL Item
    Chemotherapie (Chemotherapie)
    CL Item
    Radiotherapie (Radiotherapie)
    CL Item
    palliative Therapie (palliative Therapie)
    CL Item
    Andere (Andere)
    Other progress therapy
    Item
    andere Therapie des Progresses
    text
    C0087111 (UMLS CUI [1,1])
    C0242656 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item Group
    Administrative Dokumentation
    C1320722 (UMLS CUI-1)
    Date
    Item
    CRF-Inhalt bestätigt am:
    date
    C0011008 (UMLS CUI [1])
    Name
    Item
    Name (Druckbuchstaben)
    text
    C0027365 (UMLS CUI [1])
    Signature
    Item
    Unterschrift
    text
    C1519316 (UMLS CUI [1])
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