ID

38221

Description

Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis; ODM derived from: https://clinicaltrials.gov/show/NCT02049632

Link

https://clinicaltrials.gov/show/NCT02049632

Keywords

Versions (1)
  1. 9/29/19 9/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02049632

English

Eligibility Breast Cancer NCT02049632

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with clinically node-negative, invasive breast cancer ≤ 5 cm (t1-t2)
Description

Invasive carcinoma of breast Negative Lymph Node TNM Breast tumor staging | Tumor size

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0678034
UMLS CUI [1,3]
C0474926
UMLS CUI [2]
C0475440
histopathology results demonstrate sn micrometastases.
Description

Sentinel Lymph Node Micrometastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C1513276
patients who undergo breast-conserving surgery or mastectomy.
Description

Breast-Conserving Surgery | Mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C0917927
UMLS CUI [2]
C0024881
the patient must have given verbal and written consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
preoperatively diagnosed lymph node metastases.
Description

Secondary malignant neoplasm of lymph node Preoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0686619
UMLS CUI [1,2]
C0445204
sentinel node metastases > 2 mm.
Description

Sentinel Lymph Node Metastases Size

Data type

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0456389
metastases beyond the ipsilateral axillary lymph nodes at the time of surgery.
Description

Metastases | Axillary lymph nodes Ipsilateral Uninvolved

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C0441989
UMLS CUI [2,3]
C0205429
neoadjuvant therapy.
Description

Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0600558
history of previous breast cancer.
Description

Breast Carcinoma Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
pregnancy.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
bilateral breast cancer where any of the other exclusion criteria applies to either side.
Description

Bilateral breast cancer Associated with Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0281267
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0680251
medical contraindication for systemic adjuvant therapy
Description

Medical contraindication Adjuvant therapy Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0677850
UMLS CUI [1,3]
C0205373
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Similar models

Eligibility Breast Cancer NCT02049632

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Negative Lymph Node TNM Breast tumor staging | Tumor size
Item
patients with clinically node-negative, invasive breast cancer ≤ 5 cm (t1-t2)
boolean
C0853879 (UMLS CUI [1,1])
C0678034 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0475440 (UMLS CUI [2])
Sentinel Lymph Node Micrometastasis
Item
histopathology results demonstrate sn micrometastases.
boolean
C1522495 (UMLS CUI [1,1])
C1513276 (UMLS CUI [1,2])
Breast-Conserving Surgery | Mastectomy
Item
patients who undergo breast-conserving surgery or mastectomy.
boolean
C0917927 (UMLS CUI [1])
C0024881 (UMLS CUI [2])
Informed Consent
Item
the patient must have given verbal and written consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of lymph node Preoperative
Item
preoperatively diagnosed lymph node metastases.
boolean
C0686619 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
Sentinel Lymph Node Metastases Size
Item
sentinel node metastases > 2 mm.
boolean
C1522495 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Metastases | Axillary lymph nodes Ipsilateral Uninvolved
Item
metastases beyond the ipsilateral axillary lymph nodes at the time of surgery.
boolean
C0027627 (UMLS CUI [1])
C0729594 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])
C0205429 (UMLS CUI [2,3])
Neoadjuvant Therapy
Item
neoadjuvant therapy.
boolean
C0600558 (UMLS CUI [1])
Breast Carcinoma Previous
Item
history of previous breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Bilateral breast cancer Associated with Exclusion Criteria
Item
bilateral breast cancer where any of the other exclusion criteria applies to either side.
boolean
C0281267 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,3])
Medical contraindication Adjuvant therapy Systemic
Item
medical contraindication for systemic adjuvant therapy
boolean
C1301624 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
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