ID

14687

Description

Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.; ODM derived from: https://clinicaltrials.gov/show/NCT02240472

Link

https://clinicaltrials.gov/show/NCT02240472

Keywords

Versions (1)
  1. 4/26/16 4/26/16 -
Uploaded on

April 26, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02240472

English

Eligibility Breast Cancer NCT02240472

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Invasive breast carcinoma | Tumor stage T1 | Tumor stage T2

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0475372
UMLS CUI [3]
C0475373
n0 on palpation
Description

Node stage N0 Palpation

Data type

boolean

Alias
UMLS CUI [1,1]
C0441959
UMLS CUI [1,2]
C0030247
pathology report shows macrometastasis in 1-2 sentinel lymph nodes
Description

Macrometastasis Sentinel node | Pathology report

Data type

boolean

Alias
UMLS CUI [1,1]
C3829229
UMLS CUI [1,2]
C0677944
UMLS CUI [2]
C0807321
patients with non-palpable but cytologically and radiologically demonstrated preoperative axillary metastasis may undergo sn biopsy and be included
Description

Preoperative secondary malignant neoplasm of axilla | Sentinel Lymph Node Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0684830
UMLS CUI [1,2]
C0445204
UMLS CUI [2]
C0796693
patients undergo segmental resection or mastectomy
Description

Segmentectomy | Segmental Mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C2987624
UMLS CUI [2]
C0024885
the patient must have provided oral and written consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
extranodal growth
Description

Extranodal growth

Data type

boolean

Alias
UMLS CUI [1,1]
C1517067
UMLS CUI [1,2]
C0220844
palpable axillary metastases prior to surgery
Description

Secondary malignant neoplasm of axilla Palpable

Data type

boolean

Alias
UMLS CUI [1,1]
C0684830
UMLS CUI [1,2]
C0522499
metastases outside of the ipsilateral axilla
Description

Neoplasm Metastasis | Ipsilateral Axilla

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0441989
UMLS CUI [2,2]
C0004454
neoadjuvant therapy
Description

Neoadjuvant Therapy

Data type

boolean

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

Previous Breast Carcinoma

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
Description

bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
medical contraindication for radiotherapy
Description

Medical contraindication Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1522449
> 2 sns with macrometastases
Description

Sentinel node Macrometastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0677944
UMLS CUI [1,2]
C3829229
medical contraindication for systemic treatment
Description

Medical contraindication systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1515119
inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.
Description

Compliance behavior Limited | Disability | Inadequate language ability | Dementia

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [2]
C0231170
UMLS CUI [3,1]
C0205412
UMLS CUI [3,2]
C1145677
UMLS CUI [4]
C0497327
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Similar models

Eligibility Breast Cancer NCT02240472

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive breast carcinoma | Tumor stage T1 | Tumor stage T2
Item
patients with invasive breast cancer ≤ 5 cm (t1-t2)
boolean
C0853879 (UMLS CUI [1])
C0475372 (UMLS CUI [2])
C0475373 (UMLS CUI [3])
Node stage N0 Palpation
Item
n0 on palpation
boolean
C0441959 (UMLS CUI [1,1])
C0030247 (UMLS CUI [1,2])
Macrometastasis Sentinel node | Pathology report
Item
pathology report shows macrometastasis in 1-2 sentinel lymph nodes
boolean
C3829229 (UMLS CUI [1,1])
C0677944 (UMLS CUI [1,2])
C0807321 (UMLS CUI [2])
Preoperative secondary malignant neoplasm of axilla | Sentinel Lymph Node Biopsy
Item
patients with non-palpable but cytologically and radiologically demonstrated preoperative axillary metastasis may undergo sn biopsy and be included
boolean
C0684830 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0796693 (UMLS CUI [2])
Segmentectomy | Segmental Mastectomy
Item
patients undergo segmental resection or mastectomy
boolean
C2987624 (UMLS CUI [1])
C0024885 (UMLS CUI [2])
Informed Consent
Item
the patient must have provided oral and written consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Extranodal growth
Item
extranodal growth
boolean
C1517067 (UMLS CUI [1,1])
C0220844 (UMLS CUI [1,2])
Secondary malignant neoplasm of axilla Palpable
Item
palpable axillary metastases prior to surgery
boolean
C0684830 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
Neoplasm Metastasis | Ipsilateral Axilla
Item
metastases outside of the ipsilateral axilla
boolean
C0027627 (UMLS CUI [1])
C0441989 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
Neoadjuvant Therapy
Item
neoadjuvant therapy
boolean
C0600558 (UMLS CUI [1])
Previous Breast Carcinoma
Item
prior history of breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
bilateral breast cancer
Item
bilateral breast cancer
boolean
C0281267 (UMLS CUI [1])
Medical contraindication Therapeutic radiology procedure
Item
medical contraindication for radiotherapy
boolean
C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Sentinel node Macrometastasis
Item
> 2 sns with macrometastases
boolean
C0677944 (UMLS CUI [1,1])
C3829229 (UMLS CUI [1,2])
Medical contraindication systemic therapy
Item
medical contraindication for systemic treatment
boolean
C1301624 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
Compliance behavior Limited | Disability | Inadequate language ability | Dementia
Item
inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0231170 (UMLS CUI [2])
C0205412 (UMLS CUI [3,1])
C1145677 (UMLS CUI [3,2])
C0497327 (UMLS CUI [4])
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