ID

45880

Beschreibung

CombiCaRe Protocol of a prospective, monocentric phase I/II feasibility study investigating the safety of multimodality treatment with a combination of intraoperative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: the combiCaRe study. Roth S, Springfeld C, Diener MK, Tjaden C, Knebel P, Klaiber U, Michalski CW, Mieth M, Jäger D, Büchler MW, Hackert T.

Stichworte

Versionen (1)
  1. 10.11.23 10.11.23 - Nelly Zental
Rechteinhaber

Roth S, Springfeld C, Diener MK, Tjaden C, Knebel P, Klaiber U, Michalski CW, Mieth M, Jäger D, Büchler MW, Hackert T.

Hochgeladen am

10. November 2023

DOI

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Lizenz

Creative Commons BY 4.0
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CombiCaRe study

Englisch

Screening

12 Formulare  
  1. StudyEvent: combicare trial
    1. Screening
    2. Intervention
    3. POD 3
    4. POD 7
    5. POD 14 / Discharge
    6. POD 30
    7. POD 60/Discontinuation
    8. Signature
  2. StudyEvent: Readmission To Hospital
    1. Readmission To Hospital
  3. StudyEvent: Adverse Events
    1. Adverse Events
  4. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  5. StudyEvent: Protocol Violation
    1. Protocol violation
Record ID
Beschreibung

Record ID

Alias
UMLS CUI [1,1]
C1830337
Record ID
Beschreibung

Record ID

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
Screening
Beschreibung

Screening

Alias
UMLS CUI [1,1]
C1710477
Screening No.
Beschreibung

Screening No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
PatID
Beschreibung

PatID

Datentyp

integer

Alias
UMLS CUI [1,1]
C1269815
Date of first screening visit (day of consultation)
Beschreibung

Date of first screening visit

Datentyp

date

Alias
UMLS CUI [1,1]
C4019187
UMLS CUI [1,2]
C0009818
Date of second screening visit (start of hospital admission)
Beschreibung

Date of second screening visit

Datentyp

date

Alias
UMLS CUI [1,1]
C0205436
UMLS CUI [1,2]
C1320303
UMLS CUI [1,3]
C0184666
Informed consent
Beschreibung

Informed consent

Alias
UMLS CUI [1,1]
C0021430
Informed consent signed
Beschreibung

consent signed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0742766
Date of informed consent
Beschreibung

Date of consent

Datentyp

date

Alias
UMLS CUI [1,1]
C2985782
Inclusion criteria
Beschreibung

Inclusion criteria

Alias
UMLS CUI [1,1]
C1512693
Newly diagnosed, resectable or borderline resectable pancreatic cancer located in the head of the pancreas, without arterial involvement, on cross-sectional imaging (contrast enhanced CT scan) according to the International Study Group of Pancreatic Surgery (ISGPS) criteria
Beschreibung

new pancreatic head cancer, no arterial involvement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4763560
UMLS CUI [1,2]
C0854778
UMLS CUI [1,3]
C1518321
UMLS CUI [1,4]
C0153458
Histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants)
Beschreibung

Histology / cytology pancreatic ductal adenoca

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1335302
UMLS CUI [1,2]
C0456369
UMLS CUI [1,3]
C0497098
>=18 and <=75 years of age
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0001675
Capacity to consent
Beschreibung

Capacity to consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516240
UMLS CUI [1,2]
C0021430
Written informed consent
Beschreibung

Written informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Beschreibung

ECOG 0-2

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1520224
Patient considered to tolerate surgery and chemotherapy by a multidisciplinary team
Beschreibung

Toleration of surgery and chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C4053931
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Childbearing potential is defined according to the "Recommendations related to contraception and pregnancy testing in clinical trials" of the Clinical Trial Facilitation Group (CTFG).
Beschreibung

adequate contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4324275
UMLS CUI [1,2]
C0086582
UMLS CUI [1,3]
C1171186
UMLS CUI [1,4]
C5421123
UMLS CUI [1,5]
C5418626
Exclusion criteria
Beschreibung

Exclusion criteria

Alias
UMLS CUI [1,1]
C0680251
Distant metastatic disease
Beschreibung

Distant metastatic disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C5667514
UMLS CUI [1,2]
C2939420
Renal disease, creatinine clearance < 50 ml/min (estimated by Cockroft-Gault)
Beschreibung

Renal disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C2711451
Abnormal hepatic function as defined by a total bilirubine level >1.5 x the upper limit of normal (ULN), unless the patient has extrahepatic cholestasis due to pancreatic cancer, or alanine aminotransferase (ALT) >2.5 x ULN, liver cirrhosis (of any Child-Pugh grade)
Beschreibung

Abnormal hepatic function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0311468
UMLS CUI [1,3]
C4478307
UMLS CUI [1,4]
C0023890
UMLS CUI [1,5]
C0005398
Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris)
Beschreibung

Serious cardiovascular disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
Severe COPD, GOLD stage > II
Beschreibung

Severe COPD

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0205082
American Society of Anesthesiologists (ASA) score >III
Beschreibung

ASA score

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4061000
Active infection, including cholangitis
Beschreibung

Active infection, including cholangitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0267917
Abnormal bone marrow function, defined as an absolute white blood cell count <3/nl or platelet count <100/nl
Beschreibung

Abnormal bone marrow function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1389329
UMLS CUI [1,2]
C0750394
UMLS CUI [1,3]
C0392386
Pernicious anemia or other megaloblastic anemias where Vitamin B12 is deficient
Beschreibung

Megaloblastic anemias

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002892
UMLS CUI [1,2]
C0002888
UMLS CUI [1,3]
C2004521
Immunosuppressive therapy
Beschreibung

Immunosuppressive therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021079
Allergy or known intolerance to 5-FU or calcium folinate
Beschreibung

Allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0013182
Patients with a known lack of dihydropyrimidine-dehydrogenase (DPD)-activity or patients treated with DPD inhibitors such as brivudine
Beschreibung

Known lack of DPD-activity or DPD inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1959620
UMLS CUI [1,2]
C1511962
Current pregnancy or breastfeeding (each pregnancy that occurs within 6 months after the termination of the perioperative chemotherapy has to be reported)
Beschreibung

Current pregnancy or breastfeeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
History of another malignancy in the past 5 years
Beschreibung

Other malignancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C5452979
UMLS CUI [1,3]
C0262926
Inability to comply with study and/or follow-up procedures
Beschreibung

Inability to comply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0582786
(Language) problems in understanding the patient information document explaining the present clinical trial
Beschreibung

Problems in understanding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4693308
UMLS CUI [1,2]
C1955348
Concurrent participation in another clinical study
Beschreibung

Concurrent participation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0008976
Any condition which could result in an undue risk for the patient in the opinion of the investigator
Beschreibung

Undue risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035647
Multidisciplinary tumor board
Beschreibung

Multidisciplinary tumor board

Alias
UMLS CUI [1,1]
C5703153
UMLS CUI [1,2]
C4300109
Date of multidisciplinary tumor board
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
Demographic data
Beschreibung

Demographic data

Alias
UMLS CUI [1,1]
C4684639
Age
Beschreibung

Age

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C0001779
years
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1,1]
C0079399
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1,1]
C0005910
kg
Pregnancy test
Beschreibung

Pregnancy test

Alias
UMLS CUI [1,1]
C0032976
Person of childbearing potential
Beschreibung

Childbearing potential

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
Result of pregnancy test
Beschreibung

Pregnancy Test

Datentyp

text

Alias
UMLS CUI [1,1]
C0427777
Translational Studies
Beschreibung

Translational Studies

Alias
UMLS CUI [1,1]
C1519620
Blood sample taken (peripheral vein)
Beschreibung

Blood sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C5401001
Date blood sample taken
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1277698
Baseline clinical data
Beschreibung

Baseline clinical data

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C1516606
Kind of pancreatic cancer (based on cross-sectional imaging)
Beschreibung

Kind of pancreatic cancer

Datentyp

text

Alias
UMLS CUI [1,1]
C1880022
UMLS CUI [1,2]
C0030297
UMLS CUI [1,3]
C3824793
ASA category (according to anesthesiologist's protocol)
Beschreibung

ASA

Datentyp

text

Alias
UMLS CUI [1,1]
C1531480
ECOG performance status
Beschreibung

ECOG

Datentyp

text

Alias
UMLS CUI [1,1]
C1520224
Relevant comorbidities
Beschreibung

Relevant comorbidities

Alias
UMLS CUI [1,1]
C0009488
Cardiovascular
Beschreibung

Cardiovascular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
Pulmonary
Beschreibung

Pulmonary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024115
Renal
Beschreibung

Renal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022658
Hepatic
Beschreibung

Hepatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
Autoimmune
Beschreibung

Autoimmune

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
Infectious
Beschreibung

Infectious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
Endocrine
Beschreibung

Endocrine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0014130
Hematologic
Beschreibung

Hematologic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018939
Smoker
Beschreibung

Smoker

Datentyp

text

Alias
UMLS CUI [1,1]
C1519386
Other malignancies
Beschreibung

Other malignancies

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1869086
History of other malignancies
Beschreibung

History of other malignancies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
If yes, please specify
Beschreibung

specify malignancies

Datentyp

text

Alias
UMLS CUI [1,1]
C1521902
Year of diagnosis (of the last malignancy)
Beschreibung

Year of diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C5667275
Previous radiotherapy
Beschreibung

Previous radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
If yes, please specify region (tissue/organ)
Beschreibung

specify region

Datentyp

text

Alias
UMLS CUI [1,1]
C1521902
Start of radiotherapy (month)
Beschreibung

Month radiotherapy start

Datentyp

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0439231
Start of radiotherapy (year)
Beschreibung

Year radiotherapy start

Datentyp

integer

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0439234
End of radiotherapy (month)
Beschreibung

Month radiotherapy end

Datentyp

text

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0439231
End of radiotherapy (year)
Beschreibung

Year radiotherapy end

Datentyp

integer

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0439234
Previous chemotherapy
Beschreibung

Previous chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
If yes, please specify chemotherapy regime
Beschreibung

specify regime

Datentyp

text

Alias
UMLS CUI [1,1]
C1521902
Start of chemotherapy (month)
Beschreibung

Month chemotherapy start

Datentyp

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0439231
Start of chemotherapy (year)
Beschreibung

Year chemotherapy start

Datentyp

integer

Alias
UMLS CUI [1,2]
C0392920
UMLS CUI [1,1]
C0808070
UMLS CUI [1,3]
C0439234
End of chemotherapy (month)
Beschreibung

Month chemotherapy end

Datentyp

text

Alias
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0439231
UMLS CUI [1,1]
C0806020
End of chemotherapy (year)
Beschreibung

Year chemotherapy end

Datentyp

integer

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C0439234
Previous abdominal surgery
Beschreibung

Previous abdominal surgery

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0198482
Previous abdominal surgery
Beschreibung

Previous abdominal surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0198482
appendectomy
Beschreibung

appendectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003611
cholecystectomy
Beschreibung

cholecystectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008320
incisional hernia repair
Beschreibung

incisional hernia repair

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0342971
inguinal hernia repair
Beschreibung

inguinal hernia repair

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021446
umbilical hernia repair
Beschreibung

umbilical hernia repair

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019333
colon resection
Beschreibung

colon resection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4763870
proctologic surgery
Beschreibung

proctologic surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033248
UMLS CUI [1,2]
C0543467
small bowel surgery
Beschreibung

small bowel surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0192571
gastric surgery
Beschreibung

gastric surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0192398
hepatic surgery
Beschreibung

hepatic surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0193373
biliary surgery
Beschreibung

biliary surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005427
pancreatic surgery
Beschreibung

pancreatic surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2033062
splenectomy
Beschreibung

splenectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037995
renal surgery
Beschreibung

renal surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0194053
hysterectomy
Beschreibung

hysterectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020699
ovarectomy
Beschreibung

ovarectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029936
C-section
Beschreibung

C-section

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007876
prostate surgery
Beschreibung

prostate surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0194790
splenectomy
Beschreibung

splenectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037995
other
Beschreibung

other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
If other, please specify
Beschreibung

specify other

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1521902
Year of last surgery
Beschreibung

Year of last surgery

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439234
Type of last surgery
Beschreibung

Type of last surgery

Datentyp

text

Alias
UMLS CUI [1,1]
C0455713
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI [1,1]
C2347852
Any Concomitant Medication intake (especially coagulation)?
Beschreibung

Concomitant Medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826666
If yes, please fill out eForm 'Concomitant Medication'
Beschreibung

If yes, please fill out eForm 'Concomitant Medication'

Alias
UMLS CUI [1,1]
C3273494
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Screening

12 Formulare
  1. StudyEvent: combicare trial
    1. Screening
    2. Intervention
    3. POD 3
    4. POD 7
    5. POD 14 / Discharge
    6. POD 30
    7. POD 60/Discontinuation
    8. Signature
  2. StudyEvent: Readmission To Hospital
    1. Readmission To Hospital
  3. StudyEvent: Adverse Events
    1. Adverse Events
  4. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  5. StudyEvent: Protocol Violation
    1. Protocol violation
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Record ID
C1830337 (UMLS CUI [1,1])
Record ID
Item
Record ID
integer
C0600091 (UMLS CUI [1,1])
Item Group
Screening
C1710477 (UMLS CUI [1,1])
Screening No.
Item
Screening No.
integer
C0600091 (UMLS CUI [1,1])
PatID
Item
PatID
integer
C1269815 (UMLS CUI [1,1])
Date of first screening visit
Item
Date of first screening visit (day of consultation)
date
C4019187 (UMLS CUI [1,1])
C0009818 (UMLS CUI [1,2])
Date of second screening visit
Item
Date of second screening visit (start of hospital admission)
date
C0205436 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])
C0184666 (UMLS CUI [1,3])
Item Group
Informed consent
C0021430 (UMLS CUI [1,1])
consent signed
Item
Informed consent signed
boolean
C0742766 (UMLS CUI [1,1])
Date of consent
Item
Date of informed consent
date
C2985782 (UMLS CUI [1,1])
Item Group
Inclusion criteria
C1512693 (UMLS CUI [1,1])
new pancreatic head cancer, no arterial involvement
Item
Newly diagnosed, resectable or borderline resectable pancreatic cancer located in the head of the pancreas, without arterial involvement, on cross-sectional imaging (contrast enhanced CT scan) according to the International Study Group of Pancreatic Surgery (ISGPS) criteria
boolean
C4763560 (UMLS CUI [1,1])
C0854778 (UMLS CUI [1,2])
C1518321 (UMLS CUI [1,3])
C0153458 (UMLS CUI [1,4])
Histology / cytology pancreatic ductal adenoca
Item
Histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants)
boolean
C1335302 (UMLS CUI [1,1])
C0456369 (UMLS CUI [1,2])
C0497098 (UMLS CUI [1,3])
age
Item
>=18 and <=75 years of age
boolean
C0001779 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
Capacity to consent
Item
Capacity to consent
boolean
C1516240 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1,1])
ECOG 0-2
Item
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
boolean
C1520224 (UMLS CUI [1,1])
Toleration of surgery and chemotherapy
Item
Patient considered to tolerate surgery and chemotherapy by a multidisciplinary team
boolean
C0543467 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C4053931 (UMLS CUI [1,3])
adequate contraception
Item
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Childbearing potential is defined according to the "Recommendations related to contraception and pregnancy testing in clinical trials" of the Clinical Trial Facilitation Group (CTFG).
boolean
C4324275 (UMLS CUI [1,1])
C0086582 (UMLS CUI [1,2])
C1171186 (UMLS CUI [1,3])
C5421123 (UMLS CUI [1,4])
C5418626 (UMLS CUI [1,5])
Item Group
Exclusion criteria
C0680251 (UMLS CUI [1,1])
Distant metastatic disease
Item
Distant metastatic disease
boolean
C5667514 (UMLS CUI [1,1])
C2939420 (UMLS CUI [1,2])
Renal disease
Item
Renal disease, creatinine clearance < 50 ml/min (estimated by Cockroft-Gault)
boolean
C0022658 (UMLS CUI [1,1])
C2711451 (UMLS CUI [1,2])
Abnormal hepatic function
Item
Abnormal hepatic function as defined by a total bilirubine level >1.5 x the upper limit of normal (ULN), unless the patient has extrahepatic cholestasis due to pancreatic cancer, or alanine aminotransferase (ALT) >2.5 x ULN, liver cirrhosis (of any Child-Pugh grade)
boolean
C0086565 (UMLS CUI [1,1])
C0311468 (UMLS CUI [1,2])
C4478307 (UMLS CUI [1,3])
C0023890 (UMLS CUI [1,4])
C0005398 (UMLS CUI [1,5])
Serious cardiovascular disease
Item
Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris)
boolean
C0007222 (UMLS CUI [1,1])
Severe COPD
Item
Severe COPD, GOLD stage > II
boolean
C0024117 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
ASA score
Item
American Society of Anesthesiologists (ASA) score >III
boolean
C4061000 (UMLS CUI [1,1])
Active infection, including cholangitis
Item
Active infection, including cholangitis
boolean
C3714514 (UMLS CUI [1,1])
C0267917 (UMLS CUI [1,2])
Abnormal bone marrow function
Item
Abnormal bone marrow function, defined as an absolute white blood cell count <3/nl or platelet count <100/nl
boolean
C1389329 (UMLS CUI [1,1])
C0750394 (UMLS CUI [1,2])
C0392386 (UMLS CUI [1,3])
Megaloblastic anemias
Item
Pernicious anemia or other megaloblastic anemias where Vitamin B12 is deficient
boolean
C0002892 (UMLS CUI [1,1])
C0002888 (UMLS CUI [1,2])
C2004521 (UMLS CUI [1,3])
Immunosuppressive therapy
Item
Immunosuppressive therapy
boolean
C0021079 (UMLS CUI [1,1])
Allergy
Item
Allergy or known intolerance to 5-FU or calcium folinate
boolean
C1744706 (UMLS CUI [1,1])
C0013182 (UMLS CUI [1,2])
Known lack of DPD-activity or DPD inhibitors
Item
Patients with a known lack of dihydropyrimidine-dehydrogenase (DPD)-activity or patients treated with DPD inhibitors such as brivudine
boolean
C1959620 (UMLS CUI [1,1])
C1511962 (UMLS CUI [1,2])
Current pregnancy or breastfeeding
Item
Current pregnancy or breastfeeding (each pregnancy that occurs within 6 months after the termination of the perioperative chemotherapy has to be reported)
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Other malignancy
Item
History of another malignancy in the past 5 years
boolean
C0006826 (UMLS CUI [1,1])
C5452979 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Inability to comply
Item
Inability to comply with study and/or follow-up procedures
boolean
C0582786 (UMLS CUI [1,1])
Problems in understanding
Item
(Language) problems in understanding the patient information document explaining the present clinical trial
boolean
C4693308 (UMLS CUI [1,1])
C1955348 (UMLS CUI [1,2])
Concurrent participation
Item
Concurrent participation in another clinical study
boolean
C0205420 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Undue risk
Item
Any condition which could result in an undue risk for the patient in the opinion of the investigator
boolean
C0035647 (UMLS CUI [1,1])
Item Group
Multidisciplinary tumor board
C5703153 (UMLS CUI [1,1])
C4300109 (UMLS CUI [1,2])
Date
Item
Date of multidisciplinary tumor board
date
C0011008 (UMLS CUI [1,1])
Item Group
Demographic data
C4684639 (UMLS CUI [1,1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1,1])
Item
Gender
text
C0079399 (UMLS CUI [1,1])
CL.1
Code List
Gender
CL Item
male (1)
C0086582 (UMLS CUI [1,1])
CL Item
female (2)
C0086287 (UMLS CUI [1,1])
CL Item
other (3)
C0205394 (UMLS CUI [1,1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1,1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1,1])
Item Group
Pregnancy test
C0032976 (UMLS CUI [1,1])
Childbearing potential
Item
Person of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
Item
Result of pregnancy test
text
C0427777 (UMLS CUI [1,1])
CL.2
Code List
Result of pregnancy test
CL Item
negative (1)
C0205160 (UMLS CUI [1,1])
CL Item
positive (2)
C1446409 (UMLS CUI [1,1])
Item Group
Translational Studies
C1519620 (UMLS CUI [1,1])
Blood sample
Item
Blood sample taken (peripheral vein)
boolean
C5401001 (UMLS CUI [1,1])
Date
Item
Date blood sample taken
date
C0011008 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
Item Group
Baseline clinical data
C1442488 (UMLS CUI [1,1])
C1516606 (UMLS CUI [1,2])
Item
Kind of pancreatic cancer (based on cross-sectional imaging)
text
C1880022 (UMLS CUI [1,1])
C0030297 (UMLS CUI [1,2])
C3824793 (UMLS CUI [1,3])
CL.3
Code List
Kind of pancreatic cancer (based on cross-sectional imaging)
CL Item
resectable pancreatic cancer (1)
C0854778 (UMLS CUI [1,1])
CL Item
borderline resectable cancer (2)
C4763560 (UMLS CUI [1,1])
Item
ASA category (according to anesthesiologist's protocol)
text
C1531480 (UMLS CUI [1,1])
CL.4
Code List
ASA category (according to anesthesiologist's protocol)
CL Item
i (1)
CL Item
ii (2)
CL Item
iii (3)
CL Item
iv (4)
Item
ECOG performance status
text
C1520224 (UMLS CUI [1,1])
CL.5
Code List
ECOG performance status
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Item Group
Relevant comorbidities
C0009488 (UMLS CUI [1,1])
Cardiovascular
Item
Cardiovascular
boolean
C0007222 (UMLS CUI [1,1])
Pulmonary
Item
Pulmonary
boolean
C0024115 (UMLS CUI [1,1])
Renal
Item
Renal
boolean
C0022658 (UMLS CUI [1,1])
Hepatic
Item
Hepatic
boolean
C0023895 (UMLS CUI [1,1])
Autoimmune
Item
Autoimmune
boolean
C0004364 (UMLS CUI [1,1])
Infectious
Item
Infectious
boolean
C0009450 (UMLS CUI [1,1])
Endocrine
Item
Endocrine
boolean
C0014130 (UMLS CUI [1,1])
Hematologic
Item
Hematologic
boolean
C0018939 (UMLS CUI [1,1])
Item
Smoker
text
C1519386 (UMLS CUI [1,1])
CL.6
Code List
Smoker
CL Item
active smoker (1)
C3241966 (UMLS CUI [1,1])
CL Item
former smoker (2)
C0337671 (UMLS CUI [1,1])
CL Item
non-smoker (3)
C0337672 (UMLS CUI [1,1])
Item Group
Other malignancies
C0205394 (UMLS CUI [1,1])
C1869086 (UMLS CUI [1,2])
History of other malignancies
Item
History of other malignancies
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
specify malignancies
Item
If yes, please specify
text
C1521902 (UMLS CUI [1,1])
Year of diagnosis
Item
Year of diagnosis (of the last malignancy)
integer
C5667275 (UMLS CUI [1,1])
Previous radiotherapy
Item
Previous radiotherapy
boolean
C0279134 (UMLS CUI [1,1])
specify region
Item
If yes, please specify region (tissue/organ)
text
C1521902 (UMLS CUI [1,1])
Item
Start of radiotherapy (month)
text
C0808070 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0439231 (UMLS CUI [1,3])
CL.7
Code List
Start of radiotherapy (month)
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
unknown (13)
Year radiotherapy start
Item
Start of radiotherapy (year)
integer
C0808070 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
Item
End of radiotherapy (month)
text
C0806020 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0439231 (UMLS CUI [1,3])
CL.7
Code List
End of radiotherapy (month)
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
unknown (13)
Year radiotherapy end
Item
End of radiotherapy (year)
integer
C0806020 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
Previous chemotherapy
Item
Previous chemotherapy
boolean
C1514457 (UMLS CUI [1,1])
specify regime
Item
If yes, please specify chemotherapy regime
text
C1521902 (UMLS CUI [1,1])
Item
Start of chemotherapy (month)
text
C0808070 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0439231 (UMLS CUI [1,3])
CL.7
Code List
Start of chemotherapy (month)
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
unknown (13)
Year chemotherapy start
Item
Start of chemotherapy (year)
integer
C0392920 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,3])
Item
End of chemotherapy (month)
text
C0392920 (UMLS CUI [1,2])
C0439231 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,1])
CL.7
Code List
End of chemotherapy (month)
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
unknown (13)
Year chemotherapy end
Item
End of chemotherapy (year)
integer
C0392920 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
Item Group
Previous abdominal surgery
C0262926 (UMLS CUI [1,1])
C0198482 (UMLS CUI [1,2])
Previous abdominal surgery
Item
Previous abdominal surgery
boolean
C0205156 (UMLS CUI [1,1])
C0198482 (UMLS CUI [1,2])
appendectomy
Item
appendectomy
boolean
C0003611 (UMLS CUI [1,1])
cholecystectomy
Item
cholecystectomy
boolean
C0008320 (UMLS CUI [1,1])
incisional hernia repair
Item
incisional hernia repair
boolean
C0342971 (UMLS CUI [1,1])
inguinal hernia repair
Item
inguinal hernia repair
boolean
C0021446 (UMLS CUI [1,1])
umbilical hernia repair
Item
umbilical hernia repair
boolean
C0019333 (UMLS CUI [1,1])
colon resection
Item
colon resection
boolean
C4763870 (UMLS CUI [1,1])
proctologic surgery
Item
proctologic surgery
boolean
C0033248 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
small bowel surgery
Item
small bowel surgery
boolean
C0192571 (UMLS CUI [1,1])
gastric surgery
Item
gastric surgery
boolean
C0192398 (UMLS CUI [1,1])
hepatic surgery
Item
hepatic surgery
boolean
C0193373 (UMLS CUI [1,1])
biliary surgery
Item
biliary surgery
boolean
C0005427 (UMLS CUI [1,1])
pancreatic surgery
Item
pancreatic surgery
boolean
C2033062 (UMLS CUI [1,1])
splenectomy
Item
splenectomy
boolean
C0037995 (UMLS CUI [1,1])
renal surgery
Item
renal surgery
boolean
C0194053 (UMLS CUI [1,1])
hysterectomy
Item
hysterectomy
boolean
C0020699 (UMLS CUI [1,1])
ovarectomy
Item
ovarectomy
boolean
C0029936 (UMLS CUI [1,1])
C-section
Item
C-section
boolean
C0007876 (UMLS CUI [1,1])
prostate surgery
Item
prostate surgery
boolean
C0194790 (UMLS CUI [1,1])
splenectomy
Item
splenectomy
boolean
C0037995 (UMLS CUI [1,1])
other
Item
other
boolean
C0205394 (UMLS CUI [1,1])
specify other
Item
If other, please specify
integer
C0205394 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Year of last surgery
Item
Year of last surgery
integer
C0439234 (UMLS CUI [1,1])
Item
Type of last surgery
text
C0455713 (UMLS CUI [1,1])
CL.9
Code List
Type of last surgery
CL Item
open (1)
C0348025 (UMLS CUI [1,1])
CL Item
minimally invasive (2)
C2711297 (UMLS CUI [1,1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI [1,1])
Concomitant Medication
Item
Any Concomitant Medication intake (especially coagulation)?
boolean
C2826666 (UMLS CUI [1,1])
Item Group
If yes, please fill out eForm 'Concomitant Medication'
C3273494 (UMLS CUI [1,1])
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