ID

37841

Beskrivning

Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01120158

Länk

https://clinicaltrials.gov/show/NCT01120158

Nyckelord

Versioner (1)
  1. 2019-08-27 2019-08-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 augusti 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Breast Cancer NCT01120158

Engelsk

Eligibility Breast Cancer NCT01120158

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Breast adenocarcinoma metastatic

Datatyp

boolean

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

Prior Therapy Absent Neoplasm Metastasis | Exception Hormone Therapy

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

WHO performance status scale

Datatyp

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)
Beskrivning

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

Datatyp

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)
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

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

Bone Marrow function | Neutrophil count | Platelet Count measurement

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Metastatic malignant neoplasm to brain Progressive Absent

Datatyp

boolean

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

Absence Metastatic malignant neoplasm to brain Without Prior radiation therapy

Datatyp

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
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection
Beskrivning

Communicable Disease

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Cerebrovascular accident

Datatyp

boolean

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

Anticoagulation Therapy | Exception Aspirin Low Dose

Datatyp

boolean

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

Cancer Other Invasive | Exception Skin carcinoma

Datatyp

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
Beskrivning

Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT01120158

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial