ID

31546

Beskrivning

RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC); ODM derived from: https://clinicaltrials.gov/show/NCT00830895 Sponsor: Seoul National University Hospital Information provided by (Responsible Party): Se-Hoon Lee, Seoul National University Hospital

Länk

https://clinicaltrials.gov/show/NCT00830895

Nyckelord

Versioner (1)
  1. 2018-09-03 2018-09-03 -
Rättsinnehavare

Se-Hoon Lee, Associate Professor, Seoul National University Hospital

Uppladdad den

3 september 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Renal Cell Carcinoma NCT00830895

Engelsk

Eligibility Renal Cell Carcinoma NCT00830895

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly)
Beskrivning

Histological confirmation of a non-clear cell renal carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449575
UMLS CUI [1,2]
C0007134
2. subjects with metastatic legion
Beskrivning

Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
3. subjects aged 18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. subjects whose ecog performance status is 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
5. subjects who have laboratory value below; hematology
Beskrivning

Hematological laboratory value

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0474523
neutrophil >= 1.5 x 109/l
Beskrivning

Neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0200633
UMLS CUI [1,2]
C0205217
platelet >= 75 x 109/l
Beskrivning

Platelet count

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C0205217
hemoglobin >= 9 g/dl liver function tests
Beskrivning

Hemoglobin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019046
UMLS CUI [1,2]
C0205217
total bilirubin ≤ 1.5 xuln
Beskrivning

Bilirubin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C0205217
ast, alt ≤ 2.5 xuln
Beskrivning

AST, ALT levels

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
alkaline phosphatase ≤ 2.5 xuln renal function tests
Beskrivning

Alkaline phosphatase

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C0205217
creatinine clearance >= 30 ml/min
Beskrivning

Creatinine clearance

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
6. subjects who understand and provide a written informed consent
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects who have been administered an mtor inhibitor
Beskrivning

Administration of an mtor inhibitor

Datatyp

boolean

Alias
UMLS CUI [1]
C2746052
2. pregnant or nursing women, and women of childbearing potential must use appropriate contraception for the study period and the result of their pregnancy test performed within 14 days before enrollment must be negative
Beskrivning

Pregnancy or breastfeeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. subjects who participated in a clinical study using the study medication within 30 days before randomization
Beskrivning

Former use of study medication

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
4. subjects with clinically uncontrolled central nervous system (cns) metastasis
Beskrivning

CNS metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
5. subjects with life expectancy of less than 3 months
Beskrivning

Life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
6. subjects with interstitial pulmonary disease
Beskrivning

Interstitial pulmonary disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0206062
7. subjects whose qtc interval is prolonged (qtc > 450 msec for male or > 470 msec for female)
Beskrivning

Prolongation of qtc interval

Datatyp

boolean

Alias
UMLS CUI [1]
C0151878
8. other serious diseases or medical conditions heart disease unstable despite treatment history of myocardial infarction within six months before the study history of serious neurological or psychological disorder including dementia or seizure active peptic ulcer which cannot be controlled by a drug
Beskrivning

Concomitant serious diseases or medical conditions

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0205404
UMLS CUI [5]
C0497327
UMLS CUI [6]
C0036572
UMLS CUI [7]
C0030920
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Similar models

Eligibility Renal Cell Carcinoma NCT00830895

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Histological confirmation of a non-clear cell renal carcinoma
Item
1. histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly)
boolean
C0449575 (UMLS CUI [1,1])
C0007134 (UMLS CUI [1,2])
Metastasis
Item
2. subjects with metastatic legion
boolean
C0027627 (UMLS CUI [1])
Age
Item
3. subjects aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. subjects whose ecog performance status is 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hematological laboratory value
Item
5. subjects who have laboratory value below; hematology
boolean
C0022877 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Neutrophil count
Item
neutrophil >= 1.5 x 109/l
boolean
C0200633 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
Platelet count
Item
platelet >= 75 x 109/l
boolean
C0032181 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
Hemoglobin
Item
hemoglobin >= 9 g/dl liver function tests
boolean
C0019046 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
Bilirubin
Item
total bilirubin ≤ 1.5 xuln
boolean
C0201913 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
AST, ALT levels
Item
ast, alt ≤ 2.5 xuln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Alkaline phosphatase
Item
alkaline phosphatase ≤ 2.5 xuln renal function tests
boolean
C0201850 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
Creatinine clearance
Item
creatinine clearance >= 30 ml/min
boolean
C0373595 (UMLS CUI [1])
Informed consent
Item
6. subjects who understand and provide a written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Administration of an mtor inhibitor
Item
1. subjects who have been administered an mtor inhibitor
boolean
C2746052 (UMLS CUI [1])
Pregnancy or breastfeeding
Item
2. pregnant or nursing women, and women of childbearing potential must use appropriate contraception for the study period and the result of their pregnancy test performed within 14 days before enrollment must be negative
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Former use of study medication
Item
3. subjects who participated in a clinical study using the study medication within 30 days before randomization
boolean
C2348568 (UMLS CUI [1])
CNS metastasis
Item
4. subjects with clinically uncontrolled central nervous system (cns) metastasis
boolean
C0686377 (UMLS CUI [1])
Life expectancy
Item
5. subjects with life expectancy of less than 3 months
boolean
C0023671 (UMLS CUI [1])
Interstitial pulmonary disease
Item
6. subjects with interstitial pulmonary disease
boolean
C0206062 (UMLS CUI [1])
Prolongation of qtc interval
Item
7. subjects whose qtc interval is prolonged (qtc > 450 msec for male or > 470 msec for female)
boolean
C0151878 (UMLS CUI [1])
Concomitant serious diseases or medical conditions
Item
8. other serious diseases or medical conditions heart disease unstable despite treatment history of myocardial infarction within six months before the study history of serious neurological or psychological disorder including dementia or seizure active peptic ulcer which cannot be controlled by a drug
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0027765 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0497327 (UMLS CUI [5])
C0036572 (UMLS CUI [6])
C0030920 (UMLS CUI [7])
Tillbaka till toppen 

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