ID

27596

Beschreibung

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

Stichworte

Versionen (2)
  1. 15/11/2017 15/11/2017 -
  2. 21/11/2017 21/11/2017 -
Rechteinhaber

Beate Rau

Hochgeladen am

21 novembre 2017

DOI

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Lizenz

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

Deutsch Englisch

Patientenrandomisation

1 Formulare  
  1. StudyEvent: ODM
    1. Patientenrandomisation
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Center ID
Beschreibung

Center ID

Datentyp

text

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

Subject identification

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Year of birth
Beschreibung

Year of birth

Datentyp

partialDate

Alias
UMLS CUI [1]
C2826771
Name
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1]
C0027365
Signature
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Fax number
Beschreibung

Fax number

Datentyp

text

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

Date

Datentyp

date

Alias
UMLS CUI [1]
C0807937
Email
Beschreibung

Email

Datentyp

text

Alias
UMLS CUI [1]
C0013849
Telephone number
Beschreibung

Telephone number

Datentyp

integer

Alias
UMLS CUI [1]
C1515258
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Gastric Cancer

Datentyp

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
Beschreibung

Date of biopsy

Datentyp

date

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

Peritoneal Staging | PCI

Datentyp

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
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Karnofsky Index
Beschreibung

Karnofsky Index

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
Informed consent obtained
Beschreibung

Informed consent obtained

Datentyp

boolean

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

Date of informed consent

Datentyp

date

Alias
UMLS CUI [1]
C2985782
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Metastases
Beschreibung

Metastases

Datentyp

boolean

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

Malignant neoplasms

Datentyp

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
Beschreibung

Chemotherapy | Radiotherapy

Datentyp

boolean

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

Acute infection

Datentyp

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
Beschreibung

Lung interstitium

Datentyp

boolean

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

acute myocardial infarct | myocardial infarct

Datentyp

boolean

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

Arrhythmias

Datentyp

boolean

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

Arterial Hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
Limited heart function
Beschreibung

Limited heart function

Datentyp

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
Beschreibung

Bone marrow function

Datentyp

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
Beschreibung

Renal function

Datentyp

boolean

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

Liver function

Datentyp

boolean

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

Active Vaccinations

Datentyp

boolean

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

Hepatitis B | Hepatitis C

Datentyp

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
Beschreibung

Pregnancy | Breast feeding

Datentyp

boolean

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

No effective contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Missing legal competence
Beschreibung

Missing legal competence

Datentyp

boolean

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

Contraindication against study medication

Datentyp

boolean

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

Study participation status

Datentyp

boolean

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

Institutionalized

Datentyp

boolean

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

Staging | stratification factors

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

Laparoscopy

Datentyp

boolean

Alias
UMLS CUI [1]
C0031150
Date of Laparoscopy
Beschreibung

Date of Laparoscopy

Datentyp

date

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

Laparotomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023038
Date of laparotomy
Beschreibung

Date of laparotomy

Datentyp

date

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

Her 2 Status

Datentyp

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
Beschreibung

Peritoneal Carcinosis Index

Datentyp

text

Alias
UMLS CUI [1]
C4049621
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Ähnliche Modelle

Patientenrandomisation

1 Formulare
  1. StudyEvent: ODM
    1. Patientenrandomisation
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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