ID

37825

Description

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

Lien

https://clinicaltrials.gov/show/NCT01112254

Mots-clés

Versions (1)
  1. 26/08/2019 26/08/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

26 août 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Breast Cancer NCT01112254

Anglais

Eligibility Breast Cancer NCT01112254

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Type de données

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.
Description

DCIS Percutaneous biopsy | DCIS with Microinvasion Percutaneous biopsy

Type de données

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.
Description

Focus Size Radiologic | Access Possible Conservative Treatment

Type de données

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
Description

Microcalcification Focus Single

Type de données

boolean

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

Age

Type de données

boolean

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

Performance status

Type de données

boolean

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

Patient Information | Informed Consent

Type de données

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
invasive carcinoma
Description

Invasive Carcinoma

Type de données

boolean

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

Microcalcification Focus Biopsy Unsuccessful | Stereotaxy

Type de données

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
Description

Lesion Bilateral

Type de données

boolean

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

MRI Unsuccessful | Claustrophobia | Hypersensitivity Serious | Artificial cardiac pacemaker

Type de données

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
Description

Refused Surgery | Mastectomy Refused

Type de données

boolean

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

Medical History Breast Carcinoma Ipsilateral

Type de données

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)
Description

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

Type de données

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
Description

Pregnancy | Possible pregnancy | Breast Feeding

Type de données

boolean

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

Person Deprivation Freedom | Guardianship of person

Type de données

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
Description

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

Type de données

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
Retour au début de la page

Similar models

Eligibility Breast Cancer NCT01112254

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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