Engels

Eligibility Breast Cancer NCT01120158

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Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed metastatic breast adenocarcinoma
Beschrijving

Breast adenocarcinoma metastatic

Datatype

boolean

Alias
UMLS CUI [1]
C1697918
no previous therapy (other than hormonal therapy) for metastatic disease is accepted
Beschrijving

Prior Therapy Absent Neoplasm Metastasis | Exception Hormone Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0279025
measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
Beschrijving

Measurable lesion Quantity | Exception Secondary malignant neoplasm of bone | Exception Ascites | Exception Pleural effusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0153690
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0003962
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0032227
performance status (who) 0-2
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
adequate liver (serum bilirubin <1.5 times the upper normal limit, ast and alt <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)
Beschrijving

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5,1]
C0494165
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0494165
UMLS CUI [6,2]
C0150312
adequate renal function (serum creatinine <1.5 times the upper normal limit)
Beschrijving

Renal function | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l)
Beschrijving

Bone Marrow function | Neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
no radiation of measurable disease (except brain metastases)
Beschrijving

Therapeutic radiology procedure Absent Measurable Disease | Exception Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1513041
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220650
no progressive brain metastases according to clinical or radiological criteria
Beschrijving

Metastatic malignant neoplasm to brain Progressive Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205329
UMLS CUI [1,3]
C0332197
no brain metastases without prior radiation therapy
Beschrijving

Absence Metastatic malignant neoplasm to brain Without Prior radiation therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0220650
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C0279134
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection
Beschrijving

Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
Beschrijving

Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0085612
history of stroke
Beschrijving

Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
anticoagulation therapy (except of low dose aspirin <325mg)
Beschrijving

Anticoagulation Therapy | Exception Aspirin Low Dose

Datatype

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2608320
other invasive malignancy except non-melanoma skin cancer
Beschrijving

Cancer Other Invasive | Exception Skin carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205281
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
psychiatric illness or social situation that would preclude study compliance
Beschrijving

Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT01120158

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma metastatic
Item
histologically or cytologically confirmed metastatic breast adenocarcinoma
boolean
C1697918 (UMLS CUI [1])
Prior Therapy Absent Neoplasm Metastasis | Exception Hormone Therapy
Item
no previous therapy (other than hormonal therapy) for metastatic disease is accepted
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
Measurable lesion Quantity | Exception Secondary malignant neoplasm of bone | Exception Ascites | Exception Pleural effusion
Item
measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0153690 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0003962 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0032227 (UMLS CUI [4,2])
WHO performance status scale
Item
performance status (who) 0-2
boolean
C1298650 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present
Item
adequate liver (serum bilirubin <1.5 times the upper normal limit, ast and alt <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0494165 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0494165 (UMLS CUI [6,1])
C0150312 (UMLS CUI [6,2])
Renal function | Creatinine measurement, serum
Item
adequate renal function (serum creatinine <1.5 times the upper normal limit)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Bone Marrow function | Neutrophil count | Platelet Count measurement
Item
bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Therapeutic radiology procedure Absent Measurable Disease | Exception Metastatic malignant neoplasm to brain
Item
no radiation of measurable disease (except brain metastases)
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1513041 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain Progressive Absent
Item
no progressive brain metastases according to clinical or radiological criteria
boolean
C0220650 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Absence Metastatic malignant neoplasm to brain Without Prior radiation therapy
Item
no brain metastases without prior radiation therapy
boolean
C0332197 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0279134 (UMLS CUI [1,4])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia
Item
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
boolean
C0018799 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5])
Cerebrovascular accident
Item
history of stroke
boolean
C0038454 (UMLS CUI [1])
Anticoagulation Therapy | Exception Aspirin Low Dose
Item
anticoagulation therapy (except of low dose aspirin <325mg)
boolean
C0003281 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2608320 (UMLS CUI [2,2])
Cancer Other Invasive | Exception Skin carcinoma
Item
other invasive malignancy except non-melanoma skin cancer
boolean
C1707251 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance
Item
psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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