ID

19606

Beschrijving

Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00398437

Link

https://clinicaltrials.gov/show/NCT00398437

Trefwoorden

  1. 14-01-17 14-01-17 -
  2. 15-01-17 15-01-17 -
  3. 20-09-21 20-09-21 -
Geüploaded op

15 januari 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00398437

Eligibility Breast Cancer NCT00398437

Criteria
Beschrijving

Criteria

histologically confirmed breast cancer
Beschrijving

Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
stage iv disease
Beschrijving

Disease TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
her2/neu-overexpression (3+ by immunohistochemistry and/or gene amplification by fluorescence in situ hybridization)
Beschrijving

ERBB2 Protein Overexpression Immunohistochemistry | HER2 gene amplification Fluorescent in Situ Hybridization

Datatype

boolean

Alias
UMLS CUI [1,1]
C1515560
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0162789
undergoing treatment with trastuzumab (herceptin®) (alone or together with chemotherapy) once weekly or 3 times weekly and has achieved responding or stable disease for ≥ 12 weeks
Beschrijving

trastuzumab frequency | Herceptin Frequency | Chemotherapy Frequency | Disease Response | Stable Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0376249
UMLS CUI [2,1]
C0338204
UMLS CUI [2,2]
C0376249
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0376249
UMLS CUI [4]
C1704632
UMLS CUI [5]
C0677946
no cns metastases (i.e., brain parenchymal lesions and/or leptomeningeal carcinomatosis)
Beschrijving

CNS metastases | Lesion of brain Parenchymal | Meningeal Carcinomatosis

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0221505
UMLS CUI [2,2]
C0682552
UMLS CUI [3]
C0220654
no uncontrolled metastatic disease at study entry
Beschrijving

Neoplasm Metastasis Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205318
hormone receptor status
Beschrijving

Hormone Receptor Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
not specified
Beschrijving

Unspecified

Datatype

boolean

Alias
UMLS CUI [1]
C0205370
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
menopausal status not specified
Beschrijving

Menopausal Status Unspecified

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513126
UMLS CUI [1,2]
C0205370
karnofsky performance status 70-100%
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
no contraindication to mri scan
Beschrijving

Medical contraindication MRI Scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0917711
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beschrijving

disease characteristic

Datatype

boolean

Alias
UMLS CUI [1]
C0599878

Similar models

Eligibility Breast Cancer NCT00398437

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Breast Carcinoma
Item
histologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1])
Disease TNM clinical staging
Item
stage iv disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
ERBB2 Protein Overexpression Immunohistochemistry | HER2 gene amplification Fluorescent in Situ Hybridization
Item
her2/neu-overexpression (3+ by immunohistochemistry and/or gene amplification by fluorescence in situ hybridization)
boolean
C1515560 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
trastuzumab frequency | Herceptin Frequency | Chemotherapy Frequency | Disease Response | Stable Disease
Item
undergoing treatment with trastuzumab (herceptin®) (alone or together with chemotherapy) once weekly or 3 times weekly and has achieved responding or stable disease for ≥ 12 weeks
boolean
C0728747 (UMLS CUI [1,1])
C0376249 (UMLS CUI [1,2])
C0338204 (UMLS CUI [2,1])
C0376249 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0376249 (UMLS CUI [3,2])
C1704632 (UMLS CUI [4])
C0677946 (UMLS CUI [5])
CNS metastases | Lesion of brain Parenchymal | Meningeal Carcinomatosis
Item
no cns metastases (i.e., brain parenchymal lesions and/or leptomeningeal carcinomatosis)
boolean
C0686377 (UMLS CUI [1])
C0221505 (UMLS CUI [2,1])
C0682552 (UMLS CUI [2,2])
C0220654 (UMLS CUI [3])
Neoplasm Metastasis Uncontrolled
Item
no uncontrolled metastatic disease at study entry
boolean
C0027627 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hormone Receptor Status
Item
hormone receptor status
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Unspecified
Item
not specified
boolean
C0205370 (UMLS CUI [1])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C1513126 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
karnofsky performance status 70-100%
boolean
C0206065 (UMLS CUI [1])
Medical contraindication MRI Scan
Item
no contraindication to mri scan
boolean
C1301624 (UMLS CUI [1,1])
C0917711 (UMLS CUI [1,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
disease characteristic
Item
see disease characteristics
boolean
C0599878 (UMLS CUI [1])

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