ID

30287

Beschrijving

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

Trefwoorden

  1. 27-05-18 27-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 mei 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Lung Neoplasms NCT00768131

Eligibility Lung Neoplasms NCT00768131

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

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

Datatype

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
Beschrijving

Prior Chemotherapy Absent | Anti-EGFR Targeted Therapy Absent

Datatype

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
Beschrijving

Tumor tissue sample Sufficient FISH test

Datatype

boolean

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

Measurable Disease

Datatype

boolean

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

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
symptomatic or uncontrolled cns metastases
Beschrijving

CNS metastases Symptomatic | CNS metastases Uncontrolled

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Renal function Inadequate | Serum creatinine raised

Datatype

boolean

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

Similar models

Eligibility Lung Neoplasms NCT00768131

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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