ID

33443

Descripción

Genomic Landscape of EGFR Mutant NSCLC Prior to Erlotinib and at the Time of Disease Progression; ODM derived from: https://clinicaltrials.gov/show/NCT02431169

Link

https://clinicaltrials.gov/show/NCT02431169

Palabras clave

Versiones (1)
  1. 9/12/18 9/12/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

9 de diciembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell-Lung NCT02431169

Inglés

Eligibility Carcinoma, Non-Small-Cell-Lung NCT02431169

1 formularios  
Criteria
Descripción

Criteria

diagnosis of metastatic stage iiib/iv lung adenocarcinoma
Descripción

LUNG CANCER ADENOCARCINOMA METASTATIC TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0746071
UMLS CUI [1,2]
C3258246
presence of known sensitizing mutations in egfr tk domain (exon 19 deletion and l858r)
Descripción

Epidermal Growth Factor Receptor Mutation | EGFR exon 19 deletion | EGFR Exon 21 L858R Mutation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C0026882
UMLS CUI [2]
C3889117
UMLS CUI [3]
C3274204
absence of known resistant mutations in the egfr tk domain (t790m)
Descripción

Absence Epidermal Growth Factor Receptor Mutation Resistant | EGFR T790M

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0034802
UMLS CUI [1,3]
C0026882
UMLS CUI [1,4]
C0332325
UMLS CUI [2]
C3274192
consented to hrpo# 201305031 ("tissue and blood acquisition for genomic analysis and collection of health information from patients with thoracic malignancies, suspected thoracic malignancies, or mesothelioma")
Descripción

Consent Clinical Trial Specified

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
up to one prior line of systemic treatment for this malignancy
Descripción

Systemic therapy Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0006826
no prior localized therapy to the biopsy site
Descripción

Absence Localized Therapy Biopsy site

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1517925
UMLS CUI [1,3]
C1301128
planned treatment with standard of care erlotinib
Descripción

Erlotinib Standard of Care Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1135135
UMLS CUI [1,2]
C2936643
UMLS CUI [1,3]
C1301732
not pregnant or breastfeeding
Descripción

Pregnancy Absent | Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
at least 18 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
able to understand and willing to sign a written informed consent document
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Carcinoma, Non-Small-Cell-Lung NCT02431169

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
LUNG CANCER ADENOCARCINOMA METASTATIC TNM clinical staging
Item
diagnosis of metastatic stage iiib/iv lung adenocarcinoma
boolean
C0746071 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Epidermal Growth Factor Receptor Mutation | EGFR exon 19 deletion | EGFR Exon 21 L858R Mutation
Item
presence of known sensitizing mutations in egfr tk domain (exon 19 deletion and l858r)
boolean
C0034802 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C3889117 (UMLS CUI [2])
C3274204 (UMLS CUI [3])
Absence Epidermal Growth Factor Receptor Mutation Resistant | EGFR T790M
Item
absence of known resistant mutations in the egfr tk domain (t790m)
boolean
C0332197 (UMLS CUI [1,1])
C0034802 (UMLS CUI [1,2])
C0026882 (UMLS CUI [1,3])
C0332325 (UMLS CUI [1,4])
C3274192 (UMLS CUI [2])
Consent Clinical Trial Specified
Item
consented to hrpo# 201305031 ("tissue and blood acquisition for genomic analysis and collection of health information from patients with thoracic malignancies, suspected thoracic malignancies, or mesothelioma")
boolean
C1511481 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Systemic therapy Malignant Neoplasms
Item
up to one prior line of systemic treatment for this malignancy
boolean
C1515119 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Absence Localized Therapy Biopsy site
Item
no prior localized therapy to the biopsy site
boolean
C0332197 (UMLS CUI [1,1])
C1517925 (UMLS CUI [1,2])
C1301128 (UMLS CUI [1,3])
Erlotinib Standard of Care Planned
Item
planned treatment with standard of care erlotinib
boolean
C1135135 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Age
Item
at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
able to understand and willing to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
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