ID

35017

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02401685

Nyckelord

Versioner (1)
  1. 2019-02-10 2019-02-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 februari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02401685

Engelsk

Eligibility Breast Cancer NCT02401685

1 Formulär  
Inclusion Criteria
Beskrivning

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)
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

boolean

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

Fit Therapeutic procedure Axillary | Fit Adjuvant therapy

Datatyp

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
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
bilateral breast cancer
Beskrivning

Bilateral breast cancer

Datatyp

boolean

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

Number of lymph nodes with macrometastases

Datatyp

boolean

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

Neoadjuvant Therapy Breast Carcinoma

Datatyp

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
Beskrivning

Operative Surgical Procedure Axilla Ipsilateral

Datatyp

boolean

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

Adjuvant therapy Systemic Absent

Datatyp

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
Beskrivning

Cancer Other

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Exception Carcinoma in situ of uterine cervix Treated

Datatyp

boolean

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

Exception Malignant melanoma in situ Treated

Datatyp

boolean

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

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

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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