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ID

27596

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 Studien-Patientenidentifikation Bitte tragen Sie den Patienten in die Patientenidentifikationsliste (PIL) in Ihrem Investigator Site File (ISF) ein , um dem Patienten eine Pat-ID zuzuweisen. Bitte faxen Sie die Seiten R_01 und R_02 umgehend an die Studienzentrale der Charité : 030 – 450 7 522 214

Keywords

Versions (2)
  1. 11/15/17 11/15/17 -
  2. 11/21/17 11/21/17 -
Copyright Holder

Beate Rau

Uploaded on

November 21, 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 English

    Patientenrandomisation

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

    Administrative Documentation

    Alias
    UMLS CUI-1
    C1320722
    Center ID
    Description

    Center ID

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Subject identification
    Description

    Subject identification

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Year of birth
    Description

    Year of birth

    Data type

    partialDate

    Alias
    UMLS CUI [1]
    C2826771
    Name
    Description

    Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027365
    Signature
    Description

    Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519316
    Fax number
    Description

    Fax number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1549619
    UMLS CUI [1,2]
    C0565990
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0807937
    Email
    Description

    Email

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013849
    Telephone number
    Description

    Telephone number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1515258
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    UMLS CUI-2
    C1516637
    Gastric Cancer
    Description

    Gastric Cancer

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0699791
    UMLS CUI [1,2]
    C0445092
    UMLS CUI [1,3]
    C0346990
    UMLS CUI [1,4]
    C0332300
    UMLS CUI [1,5]
    C0022790
    Date of biopsy
    Description

    Date of biopsy

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C0011008
    Peritoneal Staging | PCI
    Description

    Peritoneal Staging | PCI

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0442034
    UMLS CUI [1,2]
    C0205699
    UMLS CUI [1,3]
    C0031150
    UMLS CUI [1,4]
    C1314939
    UMLS CUI [1,5]
    C0449820
    Age
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Karnofsky Index
    Description

    Karnofsky Index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    Informed consent obtained
    Description

    Informed consent obtained

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Date of informed consent
    Description

    Date of informed consent

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985782
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Metastases
    Description

    Metastases

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0332300
    UMLS CUI [1,4]
    C0022790
    Malignant neoplasms
    Description

    Malignant neoplasms

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0332300
    UMLS CUI [1,4]
    C0007117
    UMLS CUI [1,5]
    C0302592
    UMLS CUI [1,6]
    C1273390
    Chemotherapy | Radiotherapy
    Description

    Chemotherapy | Radiotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0699791
    UMLS CUI [2,1]
    C0279134
    UMLS CUI [2,2]
    C0699791
    Acute infection
    Description

    Acute infection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0275518
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [2,1]
    C0021368
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0087111
    Lung interstitium
    Description

    Lung interstitium

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024109
    UMLS CUI [1,2]
    C1515926
    UMLS CUI [1,3]
    C1319795
    acute myocardial infarct | myocardial infarct
    Description

    acute myocardial infarct | myocardial infarct

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0155626
    UMLS CUI [2,1]
    C0027051
    UMLS CUI [2,2]
    C0018801
    UMLS CUI [2,3]
    C0278962
    Arrhythmias
    Description

    Arrhythmias

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003811
    UMLS CUI [1,2]
    C0678227
    UMLS CUI [1,3]
    C0948268
    Arterial Hypertension
    Description

    Arterial Hypertension

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020538
    Limited heart function
    Description

    Limited heart function

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C0232164
    UMLS CUI [1,3]
    C0439801
    UMLS CUI [1,4]
    C2700378
    Bone marrow function
    Description

    Bone marrow function

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0678852
    UMLS CUI [1,2]
    C0005953
    UMLS CUI [1,3]
    C0031843
    UMLS CUI [1,4]
    C0200633
    UMLS CUI [1,5]
    C0005821
    Renal function
    Description

    Renal function

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232804
    UMLS CUI [1,2]
    C0017654
    Liver function
    Description

    Liver function

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C0344395
    Active Vaccinations
    Description

    Active Vaccinations

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042196
    Hepatitis B | Hepatitis C
    Description

    Hepatitis B | Hepatitis C

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019163
    UMLS CUI [1,2]
    C3714514
    UMLS CUI [1,3]
    C0205177
    UMLS CUI [2,1]
    C0019196
    UMLS CUI [2,2]
    C3714514
    UMLS CUI [2,3]
    C0205177
    Pregnancy | Breast feeding
    Description

    Pregnancy | Breast feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    No effective contraception
    Description

    No effective contraception

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    Missing legal competence
    Description

    Missing legal competence

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301860
    UMLS CUI [1,2]
    C0086035
    UMLS CUI [1,3]
    C1705492
    Contraindication against study medication
    Description

    Contraindication against study medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0013227
    Study participation status
    Description

    Study participation status

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2828389
    UMLS CUI [1,2]
    C0679823
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [1,4]
    C0205394
    Institutionalized
    Description

    Institutionalized

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0562359
    Staging | stratification factors
    Description

    Staging | stratification factors

    Alias
    UMLS CUI-1
    C1300072
    UMLS CUI-3
    C1514984
    Laparoscopy
    Description

    Laparoscopy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0031150
    Date of Laparoscopy
    Description

    Date of Laparoscopy

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0031150
    Laparotomy
    Description

    Laparotomy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023038
    Date of laparotomy
    Description

    Date of laparotomy

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0023038
    Her 2 Status
    Description

    Her 2 Status

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0332307
    UMLS CUI [1,2]
    C0242957
    UMLS CUI [1,3]
    C0678257
    UMLS CUI [1,4]
    C0699791
    Peritoneal Carcinosis Index
    Description

    Peritoneal Carcinosis Index

    Data type

    text

    Alias
    UMLS CUI [1]
    C4049621
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    Similar models

    Patientenrandomisation

    1 forms
    1. StudyEvent: ODM
      1. Patientenrandomisation
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1320722 (UMLS CUI-1)
    Center ID
    Item
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject identification
    Item
    integer
    C2348585 (UMLS CUI [1])
    Year of birth
    Item
    partialDate
    C2826771 (UMLS CUI [1])
    Name
    Item
    text
    C0027365 (UMLS CUI [1])
    Signature
    Item
    text
    C1519316 (UMLS CUI [1])
    Fax number
    Item
    text
    C1549619 (UMLS CUI [1,1])
    C0565990 (UMLS CUI [1,2])
    Date
    Item
    date
    C0807937 (UMLS CUI [1])
    Email
    Item
    text
    C0013849 (UMLS CUI [1])
    Telephone number
    Item
    integer
    C1515258 (UMLS CUI [1])
    Item Group
    C1512693 (UMLS CUI-1)
    C1516637 (UMLS CUI-2)
    Gastric Cancer
    Item
    boolean
    C0699791 (UMLS CUI [1,1])
    C0445092 (UMLS CUI [1,2])
    C0346990 (UMLS CUI [1,3])
    C0332300 (UMLS CUI [1,4])
    C0022790 (UMLS CUI [1,5])
    Date of biopsy
    Item
    date
    C0005558 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Peritoneal Staging | PCI
    Item
    boolean
    C0442034 (UMLS CUI [1,1])
    C0205699 (UMLS CUI [1,2])
    C0031150 (UMLS CUI [1,3])
    C1314939 (UMLS CUI [1,4])
    C0449820 (UMLS CUI [1,5])
    Age
    Item
    boolean
    C0001779 (UMLS CUI [1])
    Karnofsky Index
    Item
    boolean
    C0206065 (UMLS CUI [1])
    Informed consent obtained
    Item
    boolean
    C0021430 (UMLS CUI [1])
    Date of informed consent
    Item
    date
    C2985782 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI-1)
    Metastases
    Item
    boolean
    C0027627 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0332300 (UMLS CUI [1,3])
    C0022790 (UMLS CUI [1,4])
    Malignant neoplasms
    Item
    boolean
    C0006826 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0332300 (UMLS CUI [1,3])
    C0007117 (UMLS CUI [1,4])
    C0302592 (UMLS CUI [1,5])
    C1273390 (UMLS CUI [1,6])
    Chemotherapy | Radiotherapy
    Item
    boolean
    C1514457 (UMLS CUI [1,1])
    C0699791 (UMLS CUI [1,2])
    C0279134 (UMLS CUI [2,1])
    C0699791 (UMLS CUI [2,2])
    Acute infection
    Item
    boolean
    C0275518 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    C0021368 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [2,3])
    Lung interstitium
    Item
    boolean
    C0024109 (UMLS CUI [1,1])
    C1515926 (UMLS CUI [1,2])
    C1319795 (UMLS CUI [1,3])
    acute myocardial infarct | myocardial infarct
    Item
    boolean
    C0155626 (UMLS CUI [1])
    C0027051 (UMLS CUI [2,1])
    C0018801 (UMLS CUI [2,2])
    C0278962 (UMLS CUI [2,3])
    Arrhythmias
    Item
    boolean
    C0003811 (UMLS CUI [1,1])
    C0678227 (UMLS CUI [1,2])
    C0948268 (UMLS CUI [1,3])
    Arterial Hypertension
    Item
    boolean
    C0020538 (UMLS CUI [1])
    Limited heart function
    Item
    boolean
    C0018799 (UMLS CUI [1,1])
    C0232164 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    C2700378 (UMLS CUI [1,4])
    Bone marrow function
    Item
    boolean
    C0678852 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    C0031843 (UMLS CUI [1,3])
    C0200633 (UMLS CUI [1,4])
    C0005821 (UMLS CUI [1,5])
    Renal function
    Item
    boolean
    C0232804 (UMLS CUI [1,1])
    C0017654 (UMLS CUI [1,2])
    Liver function
    Item
    boolean
    C0232741 (UMLS CUI [1,1])
    C0344395 (UMLS CUI [1,2])
    Active Vaccinations
    Item
    boolean
    C0042196 (UMLS CUI [1])
    Hepatitis B | Hepatitis C
    Item
    boolean
    C0019163 (UMLS CUI [1,1])
    C3714514 (UMLS CUI [1,2])
    C0205177 (UMLS CUI [1,3])
    C0019196 (UMLS CUI [2,1])
    C3714514 (UMLS CUI [2,2])
    C0205177 (UMLS CUI [2,3])
    Pregnancy | Breast feeding
    Item
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    No effective contraception
    Item
    boolean
    C0700589 (UMLS CUI [1])
    Missing legal competence
    Item
    boolean
    C1301860 (UMLS CUI [1,1])
    C0086035 (UMLS CUI [1,2])
    C1705492 (UMLS CUI [1,3])
    Contraindication against study medication
    Item
    boolean
    C1301624 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    Study participation status
    Item
    boolean
    C2828389 (UMLS CUI [1,1])
    C0679823 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    Institutionalized
    Item
    boolean
    C0562359 (UMLS CUI [1])
    Item Group
    C1300072 (UMLS CUI-1)
    C1514984 (UMLS CUI-3)
    Laparoscopy
    Item
    boolean
    C0031150 (UMLS CUI [1])
    Date of Laparoscopy
    Item
    date
    C0011008 (UMLS CUI [1,1])
    C0031150 (UMLS CUI [1,2])
    Laparotomy
    Item
    boolean
    C0023038 (UMLS CUI [1])
    Date of laparotomy
    Item
    date
    C0011008 (UMLS CUI [1,1])
    C0023038 (UMLS CUI [1,2])
    Item
    text
    C0332307 (UMLS CUI [1,1])
    C0242957 (UMLS CUI [1,2])
    C0678257 (UMLS CUI [1,3])
    C0699791 (UMLS CUI [1,4])
    Her 2 Status
    Code List
    Her 2 Status
    CL Item
     (positiv)
    CL Item
     (negativ)
    CL Item
     (unbekannt)
    Item
    text
    C4049621 (UMLS CUI [1])
    Peritoneal Carcinosis Index
    Code List
    Peritoneal Carcinosis Index
    CL Item
     (gering (PCI ≤ 6))
    CL Item
     (mäßig (PCI ≥ 7 und ≤ 13))
    CL Item
     (fortgeschritten (PCI > 13))
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