ID

18548

Beschrijving

Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00137800

Link

https://clinicaltrials.gov/show/NCT00137800

Trefwoorden

Versies (1)
  1. 10-11-16 10-11-16 -
Geüploaded op

10 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Carcinoma NCT00137800

Engels

Eligibility Non-Small-Cell Lung Carcinoma NCT00137800

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 70 years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
stage iv or iiib non-small cell lung cancer (nsclc)
Beschrijving

Non-Small Cell Lung Carcinoma | TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3258246
measurable tumor(s)
Beschrijving

Measurable Disease Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
three or more weeks since prior radiation therapy
Beschrijving

prior radiation therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0279134
three or more weeks since prior major surgery
Beschrijving

major surgery Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0205156
must at least be able to walk and capable of taking care of oneself although unable to carry out work activities.
Beschrijving

Able to walk | Self-care interventions Capability | Work-related activity Unable

Datatype

boolean

Alias
UMLS CUI [1]
C2712089
UMLS CUI [2,1]
C0036592
UMLS CUI [2,2]
C2698977
UMLS CUI [3,1]
C0336911
UMLS CUI [3,2]
C1299582
must be up and about more than 50% of waking hours.
Beschrijving

Fit and well Daytime Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0424576
UMLS CUI [1,2]
C0332169
UMLS CUI [1,3]
C0439165
life expectancy of 8 weeks or more
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
blood tests that show kidneys, liver and bone marrow to be working adequately
Beschrijving

Blood test normal | Renal function | Liver function | Bone Marrow function

Datatype

boolean

Alias
UMLS CUI [1]
C0919709
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0005953
UMLS CUI [5]
C0031843
completely healed from previous oncologic or other major surgery
Beschrijving

Malignant Neoplasm Operative Surgical Procedures Recovered Complete | major surgery Recovered Complete

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0521108
UMLS CUI [1,4]
C0205197
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C0521108
UMLS CUI [2,3]
C0205197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy regimen for non-small cell lung cancer
Beschrijving

Prior Chemotherapy Non-Small Cell Lung Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
prior exposure to osi-774 or similar treatments such as trastuzumab, zd1839, c225, etc.
Beschrijving

OSI-774 Exposure to | trastuzumab | ZD1839

Datatype

boolean

Alias
UMLS CUI [1,1]
C1135137
UMLS CUI [1,2]
C0332157
UMLS CUI [2]
C0728747
UMLS CUI [3]
C0879396
UMLS CUI [4]
C0879636
uncontrolled central nervous system metastases
Beschrijving

CNS metastases Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
concurrent active cancer
Beschrijving

Malignant Neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
Beschrijving

Malignant Neoplasms | Cervix carcinoma Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0302592
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C1522326
prior chemotherapy for any malignant disease
Beschrijving

Prior Chemotherapy malignant disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0442867
difficulty swallowing
Beschrijving

Deglutition Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0011168
a disease or disorder that interferes with ability to digest and absorb food
Beschrijving

Disease Interferes with digest Food | Disease Interferes with food absorption

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0868946
UMLS CUI [1,4]
C0016452
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0699842
a medical condition that could make it unsafe for patient to participate in this study
Beschrijving

Medical condition Study Subject Participation Status At risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
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Similar models

Eligibility Non-Small-Cell Lung Carcinoma NCT00137800

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 70 years of age or older
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma | TNM clinical staging
Item
stage iv or iiib non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
Measurable Disease Quantity
Item
measurable tumor(s)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
prior radiation therapy
Item
three or more weeks since prior radiation therapy
boolean
C0279134 (UMLS CUI [1])
major surgery Previous
Item
three or more weeks since prior major surgery
boolean
C0679637 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Able to walk | Self-care interventions Capability | Work-related activity Unable
Item
must at least be able to walk and capable of taking care of oneself although unable to carry out work activities.
boolean
C2712089 (UMLS CUI [1])
C0036592 (UMLS CUI [2,1])
C2698977 (UMLS CUI [2,2])
C0336911 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Fit and well Daytime Percentage
Item
must be up and about more than 50% of waking hours.
boolean
C0424576 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Life Expectancy
Item
life expectancy of 8 weeks or more
boolean
C0023671 (UMLS CUI [1])
Blood test normal | Renal function | Liver function | Bone Marrow function
Item
blood tests that show kidneys, liver and bone marrow to be working adequately
boolean
C0919709 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0005953 (UMLS CUI [4])
C0031843 (UMLS CUI [5])
Malignant Neoplasm Operative Surgical Procedures Recovered Complete | major surgery Recovered Complete
Item
completely healed from previous oncologic or other major surgery
boolean
C0006826 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0521108 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0679637 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Non-Small Cell Lung Carcinoma
Item
prior chemotherapy regimen for non-small cell lung cancer
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
OSI-774 Exposure to | trastuzumab | ZD1839
Item
prior exposure to osi-774 or similar treatments such as trastuzumab, zd1839, c225, etc.
boolean
C1135137 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2])
C0879396 (UMLS CUI [3])
C0879636 (UMLS CUI [4])
CNS metastases Uncontrolled
Item
uncontrolled central nervous system metastases
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Malignant Neoplasm
Item
concurrent active cancer
boolean
C0006826 (UMLS CUI [1])
Malignant Neoplasms | Cervix carcinoma Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated
Item
malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
boolean
C0006826 (UMLS CUI [1])
C0302592 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0553723 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
Prior Chemotherapy malignant disease
Item
prior chemotherapy for any malignant disease
boolean
C1514457 (UMLS CUI [1,1])
C0442867 (UMLS CUI [1,2])
Deglutition Disorders
Item
difficulty swallowing
boolean
C0011168 (UMLS CUI [1])
Disease Interferes with digest Food | Disease Interferes with food absorption
Item
a disease or disorder that interferes with ability to digest and absorb food
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0868946 (UMLS CUI [1,3])
C0016452 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0699842 (UMLS CUI [2,3])
Medical condition Study Subject Participation Status At risk
Item
a medical condition that could make it unsafe for patient to participate in this study
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
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