ID

35017

Description

POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02401685

Lien

https://clinicaltrials.gov/show/NCT02401685

Mots-clés

Versions (1)
  1. 10/02/2019 10/02/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

10 février 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02401685

Anglais

Eligibility Breast Cancer NCT02401685

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
unifocal or multi-focal invasive tumour with lesion ≤5 cm in its largest dimension, measured pathologically or for women who are randomised intra-operatively largest tumour diameter on mammogram or ultrasound (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci)
Description

Invasive cancer Unifocal | Invasive cancer Multifocal | Largest dimension lesion size Measured Pathological | Neoplasm Diameter Largest Mammography | Neoplasm Diameter Largest Ultrasonography

Type de données

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C0443337
UMLS CUI [2,1]
C0677898
UMLS CUI [2,2]
C0205292
UMLS CUI [3,1]
C1275593
UMLS CUI [3,2]
C0444706
UMLS CUI [3,3]
C1521733
UMLS CUI [4,1]
C0027651
UMLS CUI [4,2]
C1301886
UMLS CUI [4,3]
C0443228
UMLS CUI [4,4]
C0024671
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C1301886
UMLS CUI [5,3]
C0443228
UMLS CUI [5,4]
C0041618
at sentinel node biopsy have 1 or 2 sentinel nodes with macrometastases (tumour deposit >2.0mm in largest dimension or defined as macrometastasis on molecular assay)
Description

Sentinel Node Number of lymph nodes with macrometastases Sentinel Lymph Node Biopsy

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C2733106
UMLS CUI [1,3]
C0796693
fit for axillary treatment and adjuvant therapy
Description

Fit Therapeutic procedure Axillary | Fit Adjuvant therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0424576
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0004454
UMLS CUI [2,1]
C0424576
UMLS CUI [2,2]
C0677850
have given written informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bilateral breast cancer
Description

Bilateral breast cancer

Type de données

boolean

Alias
UMLS CUI [1]
C0281267
more than 2 nodes with macrometastases
Description

Number of lymph nodes with macrometastases

Type de données

boolean

Alias
UMLS CUI [1]
C2733106
neoadjuvant therapy for breast cancer
Description

Neoadjuvant Therapy Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0678222
previous axillary surgery on the same body side as the scheduled sentinel node biopsy
Description

Operative Surgical Procedure Axilla Ipsilateral

Type de données

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0004454
UMLS CUI [1,3]
C0441989
not receiving adjuvant systemic therapy
Description

Adjuvant therapy Systemic Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0332197
previous cancer less than 5 years previously or concomitant malignancy except
Description

Cancer Other

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
adequately treated basal or squamous cell carcinoma of the skin
Description

Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0007117
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0553723
UMLS CUI [2,3]
C1522326
adequately treated in situ carcinoma of the cervix
Description

Exception Carcinoma in situ of uterine cervix Treated

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0851140
UMLS CUI [1,3]
C1522326
adequately treated in situ melanoma
Description

Exception Malignant melanoma in situ Treated

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0854696
UMLS CUI [1,3]
C1522326
contra- or ipsilateral in situ breast cancer
Description

Exception Contralateral breast cancer In situ | Exception Breast Carcinoma In situ Ipsilateral

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C1096616
UMLS CUI [1,3]
C0444498
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0444498
UMLS CUI [2,4]
C0441989
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Similar models

Eligibility Breast Cancer NCT02401685

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Invasive cancer Unifocal | Invasive cancer Multifocal | Largest dimension lesion size Measured Pathological | Neoplasm Diameter Largest Mammography | Neoplasm Diameter Largest Ultrasonography
Item
unifocal or multi-focal invasive tumour with lesion ≤5 cm in its largest dimension, measured pathologically or for women who are randomised intra-operatively largest tumour diameter on mammogram or ultrasound (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci)
boolean
C0677898 (UMLS CUI [1,1])
C0443337 (UMLS CUI [1,2])
C0677898 (UMLS CUI [2,1])
C0205292 (UMLS CUI [2,2])
C1275593 (UMLS CUI [3,1])
C0444706 (UMLS CUI [3,2])
C1521733 (UMLS CUI [3,3])
C0027651 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0443228 (UMLS CUI [4,3])
C0024671 (UMLS CUI [4,4])
C0027651 (UMLS CUI [5,1])
C1301886 (UMLS CUI [5,2])
C0443228 (UMLS CUI [5,3])
C0041618 (UMLS CUI [5,4])
Sentinel Node Number of lymph nodes with macrometastases Sentinel Lymph Node Biopsy
Item
at sentinel node biopsy have 1 or 2 sentinel nodes with macrometastases (tumour deposit >2.0mm in largest dimension or defined as macrometastasis on molecular assay)
boolean
C1522495 (UMLS CUI [1,1])
C2733106 (UMLS CUI [1,2])
C0796693 (UMLS CUI [1,3])
Fit Therapeutic procedure Axillary | Fit Adjuvant therapy
Item
fit for axillary treatment and adjuvant therapy
boolean
C0424576 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0004454 (UMLS CUI [1,3])
C0424576 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
Informed Consent
Item
have given written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bilateral breast cancer
Item
bilateral breast cancer
boolean
C0281267 (UMLS CUI [1])
Number of lymph nodes with macrometastases
Item
more than 2 nodes with macrometastases
boolean
C2733106 (UMLS CUI [1])
Neoadjuvant Therapy Breast Carcinoma
Item
neoadjuvant therapy for breast cancer
boolean
C0600558 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Operative Surgical Procedure Axilla Ipsilateral
Item
previous axillary surgery on the same body side as the scheduled sentinel node biopsy
boolean
C0543467 (UMLS CUI [1,1])
C0004454 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
Adjuvant therapy Systemic Absent
Item
not receiving adjuvant systemic therapy
boolean
C0677850 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Cancer Other
Item
previous cancer less than 5 years previously or concomitant malignancy except
boolean
C1707251 (UMLS CUI [1])
Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
adequately treated basal or squamous cell carcinoma of the skin
boolean
C1705847 (UMLS CUI [1,1])
C0007117 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0553723 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Exception Carcinoma in situ of uterine cervix Treated
Item
adequately treated in situ carcinoma of the cervix
boolean
C1705847 (UMLS CUI [1,1])
C0851140 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
Exception Malignant melanoma in situ Treated
Item
adequately treated in situ melanoma
boolean
C1705847 (UMLS CUI [1,1])
C0854696 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
Exception Contralateral breast cancer In situ | Exception Breast Carcinoma In situ Ipsilateral
Item
contra- or ipsilateral in situ breast cancer
boolean
C1705847 (UMLS CUI [1,1])
C1096616 (UMLS CUI [1,2])
C0444498 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0444498 (UMLS CUI [2,3])
C0441989 (UMLS CUI [2,4])
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