Engels

Eligibility Metastatic Colorectal Cancer NCT02322736

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Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patient (age ≥18 years) at enrollment
Beschrijving

Adult | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histological documentation of mcrc diagnosis
Beschrijving

Colorectal cancer metastatic

Datatype

boolean

Alias
UMLS CUI [1]
C0948380
ras wt tumor documented before study enrolment as per routine laboratory finding
Beschrijving

Neoplasm RAS Wild Type Laboratory Procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C4331207
UMLS CUI [1,3]
C0022885
subjects whose care will be managed primarily by the enrolling physician and/or all records will be available
Beschrijving

Patient care Enrollment Physician

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017313
UMLS CUI [1,2]
C1516879
UMLS CUI [1,3]
C0031831
measurable disease at baseline (preferably according to the response evaluation criteria in solid tumors version 1.1 (recist v1.1) if routinely used)
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
currently under (begin up to 8 weeks before informed consent) a 1st or 2nd line treatment regimen, including vectibix® as per indication
Beschrijving

First line treatment | Second line treatment | Indication Vectibix

Datatype

boolean

Alias
UMLS CUI [1]
C1708063
UMLS CUI [2]
C1710038
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C1743549
tumor assessment (i.e. ct/mri) within 12 weeks prior to first vectibix® infusion
Beschrijving

Neoplasm Assessment CT | Neoplasm Assessment MRI | Status pre- Vectibix Infusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0024485
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C1743549
UMLS CUI [3,3]
C1827465
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in any interventional clinical study (currently or during the three previous months from enrollment).
Beschrijving

Study Subject Participation Status | Interventional Study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
compromised ability to give informed consent (defined per clinical judgment).
Beschrijving

Ability Limited Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0021430
unknown or mutant ras tumor type
Beschrijving

Tumor type Unknown | Tumor type Mutant RAS

Datatype

boolean

Alias
UMLS CUI [1,1]
C4263544
UMLS CUI [1,2]
C0439673
UMLS CUI [2,1]
C4263544
UMLS CUI [2,2]
C4331205
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Similar models

Eligibility Metastatic Colorectal Cancer NCT02322736

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patient (age ≥18 years) at enrollment
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Colorectal cancer metastatic
Item
histological documentation of mcrc diagnosis
boolean
C0948380 (UMLS CUI [1])
Neoplasm RAS Wild Type Laboratory Procedure
Item
ras wt tumor documented before study enrolment as per routine laboratory finding
boolean
C0027651 (UMLS CUI [1,1])
C4331207 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
Patient care Enrollment Physician
Item
subjects whose care will be managed primarily by the enrolling physician and/or all records will be available
boolean
C0017313 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease at baseline (preferably according to the response evaluation criteria in solid tumors version 1.1 (recist v1.1) if routinely used)
boolean
C1513041 (UMLS CUI [1])
First line treatment | Second line treatment | Indication Vectibix
Item
currently under (begin up to 8 weeks before informed consent) a 1st or 2nd line treatment regimen, including vectibix® as per indication
boolean
C1708063 (UMLS CUI [1])
C1710038 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C1743549 (UMLS CUI [3,2])
Neoplasm Assessment CT | Neoplasm Assessment MRI | Status pre- Vectibix Infusion
Item
tumor assessment (i.e. ct/mri) within 12 weeks prior to first vectibix® infusion
boolean
C0027651 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0332152 (UMLS CUI [3,1])
C1743549 (UMLS CUI [3,2])
C1827465 (UMLS CUI [3,3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Interventional Study
Item
participation in any interventional clinical study (currently or during the three previous months from enrollment).
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
Ability Limited Informed Consent
Item
compromised ability to give informed consent (defined per clinical judgment).
boolean
C0085732 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Tumor type Unknown | Tumor type Mutant RAS
Item
unknown or mutant ras tumor type
boolean
C4263544 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
C4263544 (UMLS CUI [2,1])
C4331205 (UMLS CUI [2,2])
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