ID

38351

Description

Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy; ODM derived from: https://clinicaltrials.gov/show/NCT02112682

Link

https://clinicaltrials.gov/show/NCT02112682

Keywords

Versions (1)
  1. 10/11/19 10/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2019

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02112682

English

Eligibility Breast Neoplasms NCT02112682

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
aged 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pathologically confirmed invasive unilateral breast carcinoma
Description

Invasive carcinoma of breast Unilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205092
a clinical t1-2 tumour (including multifocal or multicentric breast cancer)
Description

Neoplasm TNM clinical staging | Multifocal breast carcinoma | Multicentric Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C2986662
UMLS CUI [3]
C2986664
will be or is treated with mastectomy
Description

Mastectomy Planned | Mastectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0024881
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0024881
clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
Description

Negative Lymph Node | Axillary lymph nodes Free of Neoplasm Metastasis | Physical Examination | Axillary Lymph Node Ultrasound Preoperative | Cytopathology finding Negative | Histopathology finding Negative

Data type

boolean

Alias
UMLS CUI [1]
C0678034
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C0027627
UMLS CUI [3]
C0031809
UMLS CUI [4,1]
C4527288
UMLS CUI [4,2]
C0445204
UMLS CUI [5,1]
C0456521
UMLS CUI [5,2]
C1513916
UMLS CUI [6,1]
C0428093
UMLS CUI [6,2]
C1513916
sentinel lymph node procedure and its pathologic evaluation should be performed according to the dutch breast cancer guideline
Description

Sentinel Lymph Node Biopsy Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0796693
UMLS CUI [1,2]
C1261322
pn1mi(sn) or pn1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases
Description

Sentinel Lymph Node TNM clinical staging | Number of lymph nodes with micrometastases Sentinel Lymph Node Axillary | Number of lymph nodes with macrometastases Sentinel Lymph Node Axillary

Data type

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C2733510
UMLS CUI [2,2]
C1522495
UMLS CUI [2,3]
C0004454
UMLS CUI [3,1]
C2733106
UMLS CUI [3,2]
C1522495
UMLS CUI [3,3]
C0004454
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically node positive pre-operative
Description

Lymph node positive Preoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0746319
UMLS CUI [1,2]
C0445204
sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
Description

Sentinel Lymph Nodes Containing Neoplastic Cells Isolated

Data type

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0597032
UMLS CUI [1,4]
C0205409
solitary parasternal sentinel lymph node metastasis (pn1b)
Description

Sentinel Lymph Node TNM clinical staging | Sentinel Lymph Node Parasternal Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1522495
UMLS CUI [2,2]
C0442146
UMLS CUI [2,3]
C0027627
bilateral breast cancer
Description

Bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization)
Description

Excision Primary tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0677930
evidence of metastatic disease
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
history of invasive breast cancer
Description

Medical History Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0853879
previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
Description

Prior surgery Axilla | Radiotherapy to axilla | Exception Operative Surgical Procedure Hidradenitis Suppurativa | Exception Operative Surgical Procedure Nevus

Data type

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0004454
UMLS CUI [2]
C1997064
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0162836
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0543467
UMLS CUI [4,3]
C0027960
pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before randomization
Description

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Breast Carcinoma Ipsilateral Treated | Exception Contralateral breast cancer Treated | Cancer treatment Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0678222
UMLS CUI [5,3]
C0441989
UMLS CUI [5,4]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1096616
UMLS CUI [6,3]
C1522326
UMLS CUI [7,1]
C0920425
UMLS CUI [7,2]
C1272705
unable or unwilling to give informed consent
Description

Informed Consent Unable | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
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Similar models

Eligibility Breast Neoplasms NCT02112682

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Invasive carcinoma of breast Unilateral
Item
pathologically confirmed invasive unilateral breast carcinoma
boolean
C0853879 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
Neoplasm TNM clinical staging | Multifocal breast carcinoma | Multicentric Breast Carcinoma
Item
a clinical t1-2 tumour (including multifocal or multicentric breast cancer)
boolean
C0027651 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C2986662 (UMLS CUI [2])
C2986664 (UMLS CUI [3])
Mastectomy Planned | Mastectomy
Item
will be or is treated with mastectomy
boolean
C0024881 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0024881 (UMLS CUI [2])
Negative Lymph Node | Axillary lymph nodes Free of Neoplasm Metastasis | Physical Examination | Axillary Lymph Node Ultrasound Preoperative | Cytopathology finding Negative | Histopathology finding Negative
Item
clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
boolean
C0678034 (UMLS CUI [1])
C0729594 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3])
C4527288 (UMLS CUI [4,1])
C0445204 (UMLS CUI [4,2])
C0456521 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C0428093 (UMLS CUI [6,1])
C1513916 (UMLS CUI [6,2])
Sentinel Lymph Node Biopsy Evaluation
Item
sentinel lymph node procedure and its pathologic evaluation should be performed according to the dutch breast cancer guideline
boolean
C0796693 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
Sentinel Lymph Node TNM clinical staging | Number of lymph nodes with micrometastases Sentinel Lymph Node Axillary | Number of lymph nodes with macrometastases Sentinel Lymph Node Axillary
Item
pn1mi(sn) or pn1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases
boolean
C1522495 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C2733510 (UMLS CUI [2,1])
C1522495 (UMLS CUI [2,2])
C0004454 (UMLS CUI [2,3])
C2733106 (UMLS CUI [3,1])
C1522495 (UMLS CUI [3,2])
C0004454 (UMLS CUI [3,3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymph node positive Preoperative
Item
clinically node positive pre-operative
boolean
C0746319 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
Sentinel Lymph Nodes Containing Neoplastic Cells Isolated
Item
sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
boolean
C1522495 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0597032 (UMLS CUI [1,3])
C0205409 (UMLS CUI [1,4])
Sentinel Lymph Node TNM clinical staging | Sentinel Lymph Node Parasternal Neoplasm Metastasis
Item
solitary parasternal sentinel lymph node metastasis (pn1b)
boolean
C1522495 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1522495 (UMLS CUI [2,1])
C0442146 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Bilateral breast cancer
Item
bilateral breast cancer
boolean
C0281267 (UMLS CUI [1])
Excision Primary tumor
Item
irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization)
boolean
C0728940 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
Neoplasm Metastasis
Item
evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1])
Medical History Invasive carcinoma of breast
Item
history of invasive breast cancer
boolean
C0262926 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
Prior surgery Axilla | Radiotherapy to axilla | Exception Operative Surgical Procedure Hidradenitis Suppurativa | Exception Operative Surgical Procedure Nevus
Item
previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
boolean
C0455610 (UMLS CUI [1,1])
C0004454 (UMLS CUI [1,2])
C1997064 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0162836 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C0027960 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Breast Carcinoma Ipsilateral Treated | Exception Contralateral breast cancer Treated | Cancer treatment Unsuccessful
Item
other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before randomization
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0678222 (UMLS CUI [5,2])
C0441989 (UMLS CUI [5,3])
C1522326 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C1096616 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C0920425 (UMLS CUI [7,1])
C1272705 (UMLS CUI [7,2])
Informed Consent Unable | Informed Consent Unwilling
Item
unable or unwilling to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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