ID

33982

Descrição

High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation; ODM derived from: https://clinicaltrials.gov/show/NCT02404675

Link

https://clinicaltrials.gov/show/NCT02404675

Palavras-chave

Versões (1)
  1. 09/01/2019 09/01/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

9 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NSCLC NCT02404675

Inglês

Eligibility NSCLC NCT02404675

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility NSCLC NCT02404675
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed stage iiib/iv lung cancer(exclude patients confirmed by sputum cytology)
Descrição

Malignant neoplasm of lung TNM clinical staging | Sputum cytology Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242379
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0551076
UMLS CUI [2,2]
C0332196
positive egfr 21 exon mutation or 19 exon deletion
Descrição

EGFR Exon 21 Mutation Positive | EGFR exon 19 deletion Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4289654
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C3889117
UMLS CUI [2,2]
C1514241
age 18-75 years old with performance status of 0 to 2
Descrição

Age | Performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1518965
with a measurable disease(longest diameters >=10mm with spiral computed tomography (ct)and >=20mm with conventional ct) according to recist criteria
Descrição

Measurable Disease | Longest Diameter Spiral CT | Longest Diameter CT

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0552406
UMLS CUI [2,2]
C0860888
UMLS CUI [3,1]
C0552406
UMLS CUI [3,2]
C0040405
adequate hematological, biochemical and organ functions.
Descrição

Hematologic function | Function Biochemical | Organ function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2,1]
C0031843
UMLS CUI [2,2]
C0205474
UMLS CUI [3]
C0678852
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Descrição

Systemic disease Severe Uncontrolled | Respiration Disorders Unstable | Heart Diseases Unstable | Liver diseases Unstable | Kidney Diseases Unstable | Respiration Disorders Uncompensated | Heart Diseases Uncompensated | Liver diseases Uncompensated | Kidney Diseases Uncompensated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0035204
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0035204
UMLS CUI [6,2]
C0205433
UMLS CUI [7,1]
C0018799
UMLS CUI [7,2]
C0205433
UMLS CUI [8,1]
C0023895
UMLS CUI [8,2]
C0205433
UMLS CUI [9,1]
C0022658
UMLS CUI [9,2]
C0205433
evidence of interstitial lung diseases
Descrição

Lung Diseases, Interstitial

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206062
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Descrição

Disease Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C3640815
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Similar models

Eligibility NSCLC NCT02404675

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility NSCLC NCT02404675
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Malignant neoplasm of lung TNM clinical staging | Sputum cytology Excluded
Item
histologically or cytologically confirmed stage iiib/iv lung cancer(exclude patients confirmed by sputum cytology)
boolean
C0242379 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0551076 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
EGFR Exon 21 Mutation Positive | EGFR exon 19 deletion Positive
Item
positive egfr 21 exon mutation or 19 exon deletion
boolean
C4289654 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C3889117 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Age | Performance status
Item
age 18-75 years old with performance status of 0 to 2
boolean
C0001779 (UMLS CUI [1])
C1518965 (UMLS CUI [2])
Measurable Disease | Longest Diameter Spiral CT | Longest Diameter CT
Item
with a measurable disease(longest diameters >=10mm with spiral computed tomography (ct)and >=20mm with conventional ct) according to recist criteria
boolean
C1513041 (UMLS CUI [1])
C0552406 (UMLS CUI [2,1])
C0860888 (UMLS CUI [2,2])
C0552406 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
Hematologic function | Function Biochemical | Organ function
Item
adequate hematological, biochemical and organ functions.
boolean
C0221130 (UMLS CUI [1])
C0031843 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
C0678852 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Systemic disease Severe Uncontrolled | Respiration Disorders Unstable | Heart Diseases Unstable | Liver diseases Unstable | Kidney Diseases Unstable | Respiration Disorders Uncompensated | Heart Diseases Uncompensated | Liver diseases Uncompensated | Kidney Diseases Uncompensated
Item
severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0035204 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0035204 (UMLS CUI [6,1])
C0205433 (UMLS CUI [6,2])
C0018799 (UMLS CUI [7,1])
C0205433 (UMLS CUI [7,2])
C0023895 (UMLS CUI [8,1])
C0205433 (UMLS CUI [8,2])
C0022658 (UMLS CUI [9,1])
C0205433 (UMLS CUI [9,2])
Lung Diseases, Interstitial
Item
evidence of interstitial lung diseases
boolean
C0206062 (UMLS CUI [1])
Disease Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable
Item
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
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