ID

23641

Beschrijving

Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00912080

Link

https://clinicaltrials.gov/show/NCT00912080

Trefwoorden

Versies (1)
  1. 10-07-17 10-07-17 -
Geüploaded op

10 juli 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00912080

Engels

Eligibility Breast Cancer NCT00912080

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
women aged between 18 and 70
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
patient with life condition < 2 (who scale)
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
one-sided breast adenocarcinoma with a histological evidence (all type)
Beschrijving

Breast adenocarcinoma Unilateral Type All

Datatype

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205092
UMLS CUI [1,3]
C0332307
UMLS CUI [1,4]
C0444868
clinical presentation which allowed a complete surgery with healthy limits
Beschrijving

Operative Surgical Procedure Complete allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0683607
absence of metastasis detectable at clinical examination or radiology
Beschrijving

Neoplasm Metastasis Absent | examination; clinical | Diagnostic radiologic examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C1456356
UMLS CUI [3]
C0043299
histological evidence for homolateral axillary ganglionic invasion, whatever is the number of node invaded (n > 1)
Beschrijving

Tumor Cell Invasion Ganglionic Axillary Ipsilateral | Lymph nodes Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0017067
UMLS CUI [1,3]
C0004454
UMLS CUI [1,4]
C0441989
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C1265611
the beginning of the chemotherapy within 6 weeks following the primary surgery
Beschrijving

Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
all metastatic affect
Beschrijving

Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
tumor classed >= t4a: cutaneous invasion, deep adherence, inflammatory breast
Beschrijving

Malignant Neoplasms TNM Breast tumor staging | Neoplasm Invasion Cutaneous | Inflammatory Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0027626
UMLS CUI [2,2]
C0221912
UMLS CUI [3]
C0278601
all chemotherapy, hormonotherapy or radiotherapy before surgery
Beschrijving

Chemotherapy Preoperative | Hormone Therapy Preoperative | Therapeutic radiology procedure Preoperative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0445204
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0445204
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0445204
tumoral residue not removed
Beschrijving

Residual Tumor

Datatype

boolean

Alias
UMLS CUI [1]
C0543478
any suspect clinic or radiologic lesion, in the contralateral breast, which is not controlled
Beschrijving

Lesion Suspicious Uncontrolled | Breast Contralateral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0750493
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0006141
UMLS CUI [2,2]
C0441988
history of invasive neoplasm, mammary or other (except in situ carcinoma of cervix uteri and epithelioma)
Beschrijving

History of invasive malignant neoplasm of breast | Invasive cancer | Carcinoma in situ of uterine cervix | Epithelioma

Datatype

boolean

Alias
UMLS CUI [1]
C4040792
UMLS CUI [2]
C0677898
UMLS CUI [3]
C0851140
UMLS CUI [4]
C1368683
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Similar models

Eligibility Breast Cancer NCT00912080

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women aged between 18 and 70
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
WHO performance status scale
Item
patient with life condition < 2 (who scale)
boolean
C1298650 (UMLS CUI [1])
Breast adenocarcinoma Unilateral Type All
Item
one-sided breast adenocarcinoma with a histological evidence (all type)
boolean
C0858252 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0444868 (UMLS CUI [1,4])
Operative Surgical Procedure Complete allowed
Item
clinical presentation which allowed a complete surgery with healthy limits
boolean
C0543467 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
Neoplasm Metastasis Absent | examination; clinical | Diagnostic radiologic examination
Item
absence of metastasis detectable at clinical examination or radiology
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1456356 (UMLS CUI [2])
C0043299 (UMLS CUI [3])
Tumor Cell Invasion Ganglionic Axillary Ipsilateral | Lymph nodes Quantity
Item
histological evidence for homolateral axillary ganglionic invasion, whatever is the number of node invaded (n > 1)
boolean
C1269955 (UMLS CUI [1,1])
C0017067 (UMLS CUI [1,2])
C0004454 (UMLS CUI [1,3])
C0441989 (UMLS CUI [1,4])
C0024204 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Chemotherapy
Item
the beginning of the chemotherapy within 6 weeks following the primary surgery
boolean
C0392920 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
all metastatic affect
boolean
C0027627 (UMLS CUI [1])
Malignant Neoplasms TNM Breast tumor staging | Neoplasm Invasion Cutaneous | Inflammatory Breast Carcinoma
Item
tumor classed >= t4a: cutaneous invasion, deep adherence, inflammatory breast
boolean
C0006826 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0027626 (UMLS CUI [2,1])
C0221912 (UMLS CUI [2,2])
C0278601 (UMLS CUI [3])
Chemotherapy Preoperative | Hormone Therapy Preoperative | Therapeutic radiology procedure Preoperative
Item
all chemotherapy, hormonotherapy or radiotherapy before surgery
boolean
C0392920 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0445204 (UMLS CUI [3,2])
Residual Tumor
Item
tumoral residue not removed
boolean
C0543478 (UMLS CUI [1])
Lesion Suspicious Uncontrolled | Breast Contralateral
Item
any suspect clinic or radiologic lesion, in the contralateral breast, which is not controlled
boolean
C0221198 (UMLS CUI [1,1])
C0750493 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0006141 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
History of invasive malignant neoplasm of breast | Invasive cancer | Carcinoma in situ of uterine cervix | Epithelioma
Item
history of invasive neoplasm, mammary or other (except in situ carcinoma of cervix uteri and epithelioma)
boolean
C4040792 (UMLS CUI [1])
C0677898 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
C1368683 (UMLS CUI [4])
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