ID

31546

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00830895

Palavras-chave

Versões (1)
  1. 03/09/2018 03/09/2018 -
Titular dos direitos

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

Transferido a

3 de setembro de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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Eligibility Renal Cell Carcinoma NCT00830895

Inglês

Eligibility Renal Cell Carcinoma NCT00830895

1 Formulários  
Inclusion Criteria
Descrição

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)
Descrição

Histological confirmation of a non-clear cell renal carcinoma

Tipo de dados

boolean

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

Metastasis

Tipo de dados

boolean

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

Age

Tipo de dados

boolean

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

ECOG performance status

Tipo de dados

boolean

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

Hematological laboratory value

Tipo de dados

boolean

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

Neutrophil count

Tipo de dados

boolean

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

Platelet count

Tipo de dados

boolean

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

Hemoglobin

Tipo de dados

boolean

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

Bilirubin

Tipo de dados

boolean

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

AST, ALT levels

Tipo de dados

boolean

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

Alkaline phosphatase

Tipo de dados

boolean

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

Creatinine clearance

Tipo de dados

boolean

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

Informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

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

Administration of an mtor inhibitor

Tipo de dados

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
Descrição

Pregnancy or breastfeeding

Tipo de dados

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
Descrição

Former use of study medication

Tipo de dados

boolean

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

CNS metastasis

Tipo de dados

boolean

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

Life expectancy

Tipo de dados

boolean

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

Interstitial pulmonary disease

Tipo de dados

boolean

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

Prolongation of qtc interval

Tipo de dados

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
Descrição

Concomitant serious diseases or medical conditions

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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