ID

35017

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02401685

Palabras clave

Versiones (1)
  1. 10/2/19 10/2/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

10 de febrero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02401685

Inglés

Eligibility Breast Cancer NCT02401685

1 formularios  
Inclusion Criteria
Descripción

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)
Descripción

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

Tipo de datos

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)
Descripción

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

Tipo de datos

boolean

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

Fit Therapeutic procedure Axillary | Fit Adjuvant therapy

Tipo de datos

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
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
bilateral breast cancer
Descripción

Bilateral breast cancer

Tipo de datos

boolean

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

Number of lymph nodes with macrometastases

Tipo de datos

boolean

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

Neoadjuvant Therapy Breast Carcinoma

Tipo de datos

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
Descripción

Operative Surgical Procedure Axilla Ipsilateral

Tipo de datos

boolean

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

Adjuvant therapy Systemic Absent

Tipo de datos

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
Descripción

Cancer Other

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

Exception Carcinoma in situ of uterine cervix Treated

Tipo de datos

boolean

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

Exception Malignant melanoma in situ Treated

Tipo de datos

boolean

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

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

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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