ID

30287

Descripción

A Study to Determine Whether EGFR Status by FISH Can Predict Results in Non Small Cell Lung Cancer (NSCLC) Patients Treated With Cetuximab, Carboplatin and Paclitaxel; ODM derived from: https://clinicaltrials.gov/show/NCT00768131

Link

https://clinicaltrials.gov/show/NCT00768131

Palabras clave

Versiones (1)
  1. 27/5/18 27/5/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de mayo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lung Neoplasms NCT00768131

Inglés

Eligibility Lung Neoplasms NCT00768131

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who present with stage iv, stage iiib nsclc or recurrent disease following radiation therapy or surgical resection
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging | Recurrent disease | Status post Therapeutic radiology procedure | Status post Excision

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1522449
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0728940
no prior chemotherapy or anti-egfr targeted therapy
Descripción

Prior Chemotherapy Absent | Anti-EGFR Targeted Therapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C4055105
UMLS CUI [2,2]
C2985566
UMLS CUI [2,3]
C0332197
sufficient tumor material for fish testing
Descripción

Tumor tissue sample Sufficient FISH test

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C0162789
measurable disease (recist)
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
ecog performance status 0 or 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
symptomatic or uncontrolled cns metastases
Descripción

CNS metastases Symptomatic | CNS metastases Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0205318
inadequate hematologic function defined as anc < 1,500/mm3, platelet count < 100,000/mm3, or a hemoglobin level < 9 g/dl
Descripción

Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
inadequate hepatic function defined as total bilirubin > 1.25 x uln, ast level > 1.5 x uln, or alkaline phosphatase > 5.0 x uln
Descripción

Liver function Inadequate | Elevated total bilirubin | Aspartate aminotransferase increased | Alkaline phosphatase raised

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151849
inadequate renal function defined by a serum creatinine level > 1.5 x uln
Descripción

Renal function Inadequate | Serum creatinine raised

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0700225
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Similar models

Eligibility Lung Neoplasms NCT00768131

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Recurrent disease | Status post Therapeutic radiology procedure | Status post Excision
Item
subjects who present with stage iv, stage iiib nsclc or recurrent disease following radiation therapy or surgical resection
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0728940 (UMLS CUI [4,2])
Prior Chemotherapy Absent | Anti-EGFR Targeted Therapy Absent
Item
no prior chemotherapy or anti-egfr targeted therapy
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4055105 (UMLS CUI [2,1])
C2985566 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Tumor tissue sample Sufficient FISH test
Item
sufficient tumor material for fish testing
boolean
C0475358 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease (recist)
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS metastases Symptomatic | CNS metastases Uncontrolled
Item
symptomatic or uncontrolled cns metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
inadequate hematologic function defined as anc < 1,500/mm3, platelet count < 100,000/mm3, or a hemoglobin level < 9 g/dl
boolean
C0221130 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function Inadequate | Elevated total bilirubin | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
inadequate hepatic function defined as total bilirubin > 1.25 x uln, ast level > 1.5 x uln, or alkaline phosphatase > 5.0 x uln
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
Renal function Inadequate | Serum creatinine raised
Item
inadequate renal function defined by a serum creatinine level > 1.5 x uln
boolean
C0232804 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0700225 (UMLS CUI [2])
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