ID

37825

Beschrijving

Evaluation of the Diagnostic Performance of MRI±Biopsy to Optimize Resection of Ductal Carcinoma In Situ (DCIS) Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01112254

Link

https://clinicaltrials.gov/show/NCT01112254

Trefwoorden

Versies (1)
  1. 26-08-19 26-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

26 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01112254

Engels

Eligibility Breast Cancer NCT01112254

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
t0 or t1 breast dcis revealed by microcalcifications on mammography + breast ultrasound
Beschrijving

DCIS TNM Breast tumor staging | Microcalcification Mammography | Microcalcification Mammary Ultrasonography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0521174
UMLS CUI [2,2]
C0024671
UMLS CUI [3,1]
C0521174
UMLS CUI [3,2]
C0080264
histological confirmation by percutaneous biopsy : strict dcis or micro-invasive.
Beschrijving

DCIS Percutaneous biopsy | DCIS with Microinvasion Percutaneous biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C0405355
UMLS CUI [2,1]
C2732473
UMLS CUI [2,2]
C0405355
radiological focus < 30mm and accessible to conservative treatment.
Beschrijving

Focus Size Radiologic | Access Possible Conservative Treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205234
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0205483
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C0332149
UMLS CUI [2,3]
C0459914
single microcalcification focus
Beschrijving

Microcalcification Focus Single

Datatype

boolean

Alias
UMLS CUI [1,1]
C0521174
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205171
age : 18 to 80 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
performance status < 2
Beschrijving

Performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
patient information and signed informed consent.
Beschrijving

Patient Information | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C1955348
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
invasive carcinoma
Beschrijving

Invasive Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C1334274
non biopsiable microcalcification focus under stereotaxy
Beschrijving

Microcalcification Focus Biopsy Unsuccessful | Stereotaxy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0521174
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0005558
UMLS CUI [1,4]
C1272705
UMLS CUI [2]
C1136207
bilateral lesions
Beschrijving

Lesion Bilateral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0238767
non feasible mri (claustrophobic, serious allergy, pace-maker, etc.)
Beschrijving

MRI Unsuccessful | Claustrophobia | Hypersensitivity Serious | Artificial cardiac pacemaker

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1272705
UMLS CUI [2]
C0008909
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0205404
UMLS CUI [4]
C0030163
refusal of surgery, including mastectomy if necessary
Beschrijving

Refused Surgery | Mastectomy Refused

Datatype

boolean

Alias
UMLS CUI [1]
C0749192
UMLS CUI [2,1]
C0024881
UMLS CUI [2,2]
C1705116
history of homolateral breast cancer
Beschrijving

Medical History Breast Carcinoma Ipsilateral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0441989
patient at risk of breast cancer (brca1 or 2 mutation or score 5 inserm table)
Beschrijving

Patient At risk Breast Carcinoma | BRCA1 gene mutation | BRCA2 gene mutation | Other Coding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0678222
UMLS CUI [2]
C1511022
UMLS CUI [3]
C1511024
UMLS CUI [4]
C3846158
pregnant or possibly pregnant or breastfeeding woman
Beschrijving

Pregnancy | Possible pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
UMLS CUI [3]
C0006147
person deprived of freedom or under guardianship
Beschrijving

Person Deprivation Freedom | Guardianship of person

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
UMLS CUI [2]
C0680611
inability to undergo the medical surveillance of the trial for geographical, social or psychological reasons
Beschrijving

Medical Surveillance Receive Unable | Etiology Geographic Factors | Etiology Social factor | Etiology Psychological Factors

Datatype

boolean

Alias
UMLS CUI [1,1]
C0733511
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0017444
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0337460
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0033898
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Similar models

Eligibility Breast Cancer NCT01112254

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
DCIS TNM Breast tumor staging | Microcalcification Mammography | Microcalcification Mammary Ultrasonography
Item
t0 or t1 breast dcis revealed by microcalcifications on mammography + breast ultrasound
boolean
C0007124 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0521174 (UMLS CUI [2,1])
C0024671 (UMLS CUI [2,2])
C0521174 (UMLS CUI [3,1])
C0080264 (UMLS CUI [3,2])
DCIS Percutaneous biopsy | DCIS with Microinvasion Percutaneous biopsy
Item
histological confirmation by percutaneous biopsy : strict dcis or micro-invasive.
boolean
C0007124 (UMLS CUI [1,1])
C0405355 (UMLS CUI [1,2])
C2732473 (UMLS CUI [2,1])
C0405355 (UMLS CUI [2,2])
Focus Size Radiologic | Access Possible Conservative Treatment
Item
radiological focus < 30mm and accessible to conservative treatment.
boolean
C0205234 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0205483 (UMLS CUI [1,3])
C0444454 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C0459914 (UMLS CUI [2,3])
Microcalcification Focus Single
Item
single microcalcification focus
boolean
C0521174 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
Age
Item
age : 18 to 80 years old
boolean
C0001779 (UMLS CUI [1])
Performance status
Item
performance status < 2
boolean
C1518965 (UMLS CUI [1])
Patient Information | Informed Consent
Item
patient information and signed informed consent.
boolean
C1955348 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Invasive Carcinoma
Item
invasive carcinoma
boolean
C1334274 (UMLS CUI [1])
Microcalcification Focus Biopsy Unsuccessful | Stereotaxy
Item
non biopsiable microcalcification focus under stereotaxy
boolean
C0521174 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
C1136207 (UMLS CUI [2])
Lesion Bilateral
Item
bilateral lesions
boolean
C0221198 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
MRI Unsuccessful | Claustrophobia | Hypersensitivity Serious | Artificial cardiac pacemaker
Item
non feasible mri (claustrophobic, serious allergy, pace-maker, etc.)
boolean
C0024485 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0030163 (UMLS CUI [4])
Refused Surgery | Mastectomy Refused
Item
refusal of surgery, including mastectomy if necessary
boolean
C0749192 (UMLS CUI [1])
C0024881 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Medical History Breast Carcinoma Ipsilateral
Item
history of homolateral breast cancer
boolean
C0262926 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
Patient At risk Breast Carcinoma | BRCA1 gene mutation | BRCA2 gene mutation | Other Coding
Item
patient at risk of breast cancer (brca1 or 2 mutation or score 5 inserm table)
boolean
C0030705 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C1511022 (UMLS CUI [2])
C1511024 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
Pregnancy | Possible pregnancy | Breast Feeding
Item
pregnant or possibly pregnant or breastfeeding woman
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Person Deprivation Freedom | Guardianship of person
Item
person deprived of freedom or under guardianship
boolean
C0027361 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
C0680611 (UMLS CUI [2])
Medical Surveillance Receive Unable | Etiology Geographic Factors | Etiology Social factor | Etiology Psychological Factors
Item
inability to undergo the medical surveillance of the trial for geographical, social or psychological reasons
boolean
C0733511 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0017444 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0337460 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0033898 (UMLS CUI [4,2])
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