ID

38123

Description

Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node; ODM derived from: https://clinicaltrials.gov/show/NCT01796444

Lien

https://clinicaltrials.gov/show/NCT01796444

Mots-clés

Versions (1)
  1. 19/09/2019 19/09/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

19 septembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01796444

Anglais

Eligibility Breast Cancer NCT01796444

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female;
Description

Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
patient aged 18 years and above;
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
patient with histological proven invasive breast cancer;
Description

Invasive carcinoma of breast

Type de données

boolean

Alias
UMLS CUI [1]
C0853879
clinical t1-t2 disease with no distant metastasis;
Description

Disease TNM Breast tumor staging | Distant metastasis Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332197
patient with clinical n0 status;
Description

TNM Breast tumor staging

Type de données

boolean

Alias
UMLS CUI [1]
C0474926
patient for whom conservative surgery with sentinel lymph node (sln) technique is feasible from the start in terms of carcinologic;
Description

Breast-Conserving Surgery Sentinel Lymph Node Technique Possible

Type de données

boolean

Alias
UMLS CUI [1,1]
C0917927
UMLS CUI [1,2]
C1522495
UMLS CUI [1,3]
C0449851
UMLS CUI [1,4]
C0332149
patient with positive slns 1~2;
Description

Sentinel Lymph Node Positive Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C1265611
signed consent to participate.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of neoadjuvant chemotherapy or hormone therapy;
Description

Neoadjuvant Chemotherapy | Neoadjuvant Hormone Therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0279025
history of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);
Description

Breast Carcinoma Ipsilateral | Breast cancer recurrent | Contralateral Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0441989
UMLS CUI [2]
C0278493
UMLS CUI [3]
C3274709
history of any other invasive cancer;
Description

Cancer Other Invasive

Type de données

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205281
initial metastatic disease known;
Description

Neoplasm Metastasis Initial

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205265
pregnant women or lactating women;
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.
Description

Medical Examination Unsuccessful | Etiology Geographic Factors | Etiology Social factor | Etiology Psychological Factors

Type de données

boolean

Alias
UMLS CUI [1,1]
C0582103
UMLS CUI [1,2]
C1272705
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 NCT01796444

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female;
boolean
C0079399 (UMLS CUI [1])
Age
Item
patient aged 18 years and above;
boolean
C0001779 (UMLS CUI [1])
Invasive carcinoma of breast
Item
patient with histological proven invasive breast cancer;
boolean
C0853879 (UMLS CUI [1])
Disease TNM Breast tumor staging | Distant metastasis Absent
Item
clinical t1-t2 disease with no distant metastasis;
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
TNM Breast tumor staging
Item
patient with clinical n0 status;
boolean
C0474926 (UMLS CUI [1])
Breast-Conserving Surgery Sentinel Lymph Node Technique Possible
Item
patient for whom conservative surgery with sentinel lymph node (sln) technique is feasible from the start in terms of carcinologic;
boolean
C0917927 (UMLS CUI [1,1])
C1522495 (UMLS CUI [1,2])
C0449851 (UMLS CUI [1,3])
C0332149 (UMLS CUI [1,4])
Sentinel Lymph Node Positive Quantity
Item
patient with positive slns 1~2;
boolean
C1522495 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Informed Consent
Item
signed consent to participate.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoadjuvant Chemotherapy | Neoadjuvant Hormone Therapy
Item
history of neoadjuvant chemotherapy or hormone therapy;
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
Breast Carcinoma Ipsilateral | Breast cancer recurrent | Contralateral Breast Carcinoma
Item
history of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);
boolean
C0678222 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2])
C3274709 (UMLS CUI [3])
Cancer Other Invasive
Item
history of any other invasive cancer;
boolean
C1707251 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
Neoplasm Metastasis Initial
Item
initial metastatic disease known;
boolean
C0027627 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant women or lactating women;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical Examination Unsuccessful | Etiology Geographic Factors | Etiology Social factor | Etiology Psychological Factors
Item
impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.
boolean
C0582103 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
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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