Informações:
Falhas:
ID
45880
Descrição
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.
Palavras-chave
Versões (1)
- 10/11/2023 10/11/2023 - Nelly Zental
Titular dos direitos
Roth S, Springfeld C, Diener MK, Tjaden C, Knebel P, Klaiber U, Michalski CW, Mieth M, Jäger D, Büchler MW, Hackert T.
Transferido a
10 de novembro de 2023
DOI
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Licença
Creative Commons BY 4.0
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CombiCaRe study
Screening
- StudyEvent: combicare trial
- StudyEvent: Readmission To Hospital
- StudyEvent: Adverse Events
- StudyEvent: Concomitant Medication
- StudyEvent: Protocol Violation
Similar models
Screening
- StudyEvent: combicare trial
- StudyEvent: Readmission To Hospital
- StudyEvent: Adverse Events
- StudyEvent: Concomitant Medication
- StudyEvent: Protocol Violation
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Record ID
Item
Record ID
integer
C0600091 (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])
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])
C1320303 (UMLS CUI [1,2])
C0184666 (UMLS CUI [1,3])
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])
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])
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])
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])
C0001675 (UMLS CUI [1,2])
Capacity to consent
Item
Capacity to consent
boolean
C1516240 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
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])
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])
C0086582 (UMLS CUI [1,2])
C1171186 (UMLS CUI [1,3])
C5421123 (UMLS CUI [1,4])
C5418626 (UMLS CUI [1,5])
Distant metastatic disease
Item
Distant metastatic disease
boolean
C5667514 (UMLS CUI [1,1])
C2939420 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C4300109 (UMLS CUI [1,2])
Date
Item
Date of multidisciplinary tumor board
date
C0011008 (UMLS CUI [1,1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1,1])
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])
Childbearing potential
Item
Person of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
CL Item
negative (1)
C0205160 (UMLS CUI [1,1])
CL Item
positive (2)
C1446409 (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])
C1277698 (UMLS CUI [1,2])
Item Group
Baseline clinical data
C1442488 (UMLS CUI [1,1])
C1516606 (UMLS CUI [1,2])
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])
C0030297 (UMLS CUI [1,2])
C3824793 (UMLS CUI [1,3])
CL Item
resectable pancreatic cancer (1)
C0854778 (UMLS CUI [1,1])
CL Item
borderline resectable cancer (2)
C4763560 (UMLS CUI [1,1])
CL Item
i (1)
CL Item
ii (2)
CL Item
iii (3)
CL Item
iv (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
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])
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])
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])
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])
C1522449 (UMLS CUI [1,2])
C0439231 (UMLS CUI [1,3])
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])
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])
C1522449 (UMLS CUI [1,2])
C0439231 (UMLS CUI [1,3])
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])
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])
C0392920 (UMLS CUI [1,2])
C0439231 (UMLS CUI [1,3])
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])
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])
C0439231 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,1])
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])
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])
C0198482 (UMLS CUI [1,2])
Previous abdominal surgery
Item
Previous abdominal surgery
boolean
C0205156 (UMLS CUI [1,1])
C0198482 (UMLS CUI [1,2])
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])
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])
C1521902 (UMLS CUI [1,2])
Year of last surgery
Item
Year of last surgery
integer
C0439234 (UMLS CUI [1,1])
CL Item
open (1)
C0348025 (UMLS CUI [1,1])
CL Item
minimally invasive (2)
C2711297 (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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