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Fel:
ID
38608
Beskrivning
c-Met Second-Line Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02115373
Länk
https://clinicaltrials.gov/show/NCT02115373
Nyckelord
Versioner (2)
- 2019-10-28 2019-10-28 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
28 oktober 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT02115373
Eligibility Carcinoma, Hepatocellular NCT02115373
- StudyEvent: Eligibility
Similar models
Eligibility Carcinoma, Hepatocellular NCT02115373
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Liver carcinoma
Item
histologically or cytologically confirmed hcc
boolean
C2239176 (UMLS CUI [1])
Liver function Child-Pugh Classification
Item
child pugh class a liver function score
boolean
C0232741 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C2347612 (UMLS CUI [1,2])
MET Positive
Item
for phase 2 only: met+ status
boolean
C4330600 (UMLS CUI [1])
Age
Item
male or female, 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Measurable Disease
Item
measurable disease in accordance with response evaluation criteria in solid tumors (recist) version 1.1
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status (ps) 0-1 (inclusive)
boolean
C1520224 (UMLS CUI [1])
Tumor Biopsy Pretreatment | Exception Fine needle aspiration biopsy | Exception Cytologic material | Sorafenib Discontinued | Tepotinib | Tumor tissue Formalin-fixed paraffin-embedded tissue specimen Block | Unstained Specimen Quantity | Pathology report
Item
availability of a pretreatment tumor biopsy (excluding fine needle aspiration and cytology samples) taken after the subject has discontinued sorafenib and within 28 days before the day of first dosing with msc2156119j. from the pretreatment biopsy either a formalin-fixed (formalin fixation is mandatory) paraffin-embedded block with tumor tissue (preferred) or at least 15 unstained slides must be sent to the central laboratory prior to enrollment. an associated pathology report must also be sent with the sample
boolean
C0027651 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C3539076 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1510483 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0225355 (UMLS CUI [3,2])
C1516119 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C4287799 (UMLS CUI [5])
C0475358 (UMLS CUI [6,1])
C2711483 (UMLS CUI [6,2])
C1533157 (UMLS CUI [6,3])
C1883469 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0807321 (UMLS CUI [8])
C0005558 (UMLS CUI [1,2])
C3539076 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1510483 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0225355 (UMLS CUI [3,2])
C1516119 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C4287799 (UMLS CUI [5])
C0475358 (UMLS CUI [6,1])
C2711483 (UMLS CUI [6,2])
C1533157 (UMLS CUI [6,3])
C1883469 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0807321 (UMLS CUI [8])
Sorafenib | Sorafenib Discontinued | Intolerance to Sorafenib | Disease Progression Radiography
Item
previously treated with sorafenib for greater than or equal to 4 weeks and discontinued sorafenib treatment at least 14 days prior to day 1 due to either intolerance or radiographic progression
boolean
C1516119 (UMLS CUI [1])
C1516119 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4,1])
C0034571 (UMLS CUI [4,2])
C1516119 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4,1])
C0034571 (UMLS CUI [4,2])
Informed Consent | Informed Consent Patient Representative
Item
signed and dated informed consent indicating that the subject (or legally acceptable representative if applicable by local laws) has been informed of all the pertinent aspects of the trial prior to enrollment
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Protocol Compliance
Item
willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures
boolean
C0525058 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months as judged by the investigator
boolean
C0023671 (UMLS CUI [1])
Cancer treatment Systemic Advanced Adult Hepatocellular Carcinoma | Exception Sorafenib
Item
prior systemic anticancer treatment for advanced hcc (except for sorafenib as described in the inclusion criteria)
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1706732 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1516119 (UMLS CUI [2,2])
C0205373 (UMLS CUI [1,2])
C1706732 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1516119 (UMLS CUI [2,2])
Targeted Therapy Hepatocyte Growth Factor | Targeted Therapy C-MET
Item
prior treatment with any agent targeting the hepatocyte growth factor (hgf)/c-met pathway
boolean
C2985566 (UMLS CUI [1,1])
C0062534 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C1456828 (UMLS CUI [2,2])
C0062534 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C1456828 (UMLS CUI [2,2])
Therapy Local-Regional
Item
local-regional therapy within 4 weeks before day 1
boolean
C0087111 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
C1947913 (UMLS CUI [1,2])
Decreased cardiac function
Item
impaired cardiac function
boolean
C0232166 (UMLS CUI [1])
Exclusion Criteria Study Protocol
Item
other protocol defined exclusion criteria could apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])