Informações:
Falhas:
ID
36400
Descrição
Prospective Observational Study of 1st and 2nd Line Vectibix® Use in RAS-wt mCRC Pts to Evaluate Pattern of Use and ORR; ODM derived from: https://clinicaltrials.gov/show/NCT02322736
Link
https://clinicaltrials.gov/show/NCT02322736
Palavras-chave
Versões (1)
- 10/05/2019 10/05/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
10 de maio de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT02322736
Eligibility Metastatic Colorectal Cancer NCT02322736
- StudyEvent: Eligibility
Similar models
Eligibility Metastatic Colorectal Cancer NCT02322736
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Adult | Age
Item
adult patient (age ≥18 years) at enrollment
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
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])
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])
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])
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])
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])
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])
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])
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])
C0439673 (UMLS CUI [1,2])
C4263544 (UMLS CUI [2,1])
C4331205 (UMLS CUI [2,2])