Registration
Item
at registration
boolean
C1514821 (UMLS CUI [1])
Informed Consent
Item
patient has given written informed consent before registration
boolean
C0021430 (UMLS CUI [1])
Gender | Excision of axillary lymph nodes | Sentinel Lymph Node Frozen Sections
Item
female patients; eligible for primary alnd or sentinel lymph node procedure with frozen section and either:
boolean
C0079399 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
C1522495 (UMLS CUI [3,1])
C0016741 (UMLS CUI [3,2])
Newly Diagnosed
Item
newly diagnosed
boolean
C1518321 (UMLS CUI [1])
Breast Carcinoma | Female breast | Entire chest wall | Axilla
Item
or recurrent breast cancer in the conserved breast, chest wall or axilla
boolean
C0678222 (UMLS CUI [1])
C0222603 (UMLS CUI [2])
C1279035 (UMLS CUI [3])
C0004454 (UMLS CUI [4])
Breast Carcinoma | UICC (tumor staging) | AJCC tumor staging
Item
patients with histo- or cytology proven breast cancer uicc/ajcc stage i-iii
boolean
C0678222 (UMLS CUI [1])
C0441914 (UMLS CUI [2])
C0441915 (UMLS CUI [3])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Able to speak fluently German language | Able to speak fluently French language | Able to speak fluently Italian language | Able to speak fluently Spanish Language | Able to speak fluently Turkish language | Able to speak fluently English Language
Item
fluency in either german, french, italian, spanish, turkish or english
boolean
C0564241 (UMLS CUI [1,1])
C0017477 (UMLS CUI [1,2])
C0564241 (UMLS CUI [2,1])
C0376246 (UMLS CUI [2,2])
C0564241 (UMLS CUI [3,1])
C0022275 (UMLS CUI [3,2])
C0564241 (UMLS CUI [4,1])
C0037750 (UMLS CUI [4,2])
C0564241 (UMLS CUI [5,1])
C0041402 (UMLS CUI [5,2])
C0564241 (UMLS CUI [6,1])
C0376245 (UMLS CUI [6,2])
EuroQoL five dimension questionnaire Complete
Item
the eq-5d questionnaire has been completed at registration
boolean
C2733251 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Pregnancy | Operative Surgical Procedures
Item
patient with child-bearing potential, willing to use effective contraception, not currently pregnant and agreeing not to become pregnant after trial registration and during the 24 weeks after surgery
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Pregnancy test negative Childbearing Potential
Item
a negative pregnancy test within 14 days prior to inclusion is available for all women with child-bearing potential
boolean
C0427780 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
Inclusion | Randomization
Item
inclusion criteria at randomization
boolean
C1512693 (UMLS CUI [1])
C0034656 (UMLS CUI [2])
Excision of axillary lymph nodes Indicated | Breast-Conserving Surgery
Item
alnd indicated according to clinical standards, either as single procedure or in combination with breast conserving surgery
boolean
C0193867 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])
C0917927 (UMLS CUI [2])
Exclusion Criteria | Registration
Item
exclusion criteria at registration:
boolean
C0680251 (UMLS CUI [1])
C1514821 (UMLS CUI [2])
Hypersensitivity TachoSil | Hypersensitivity Fibrin Tissue Adhesive
Item
known hypersensitivity for tachosil® or fibrin sealant
boolean
C0020517 (UMLS CUI [1,1])
C1871272 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0016004 (UMLS CUI [2,2])
Mastectomy | Drain device Axilla
Item
patients with mastectomy (simultaneously or within 1 month before registration); patients undergoing completion mastectomy at a later day will remain eligible and are evaluable for analysis according to intention to treat. if the axillary drain is still in place at the time of completion mastectomy and a separate drain is inserted underneath the skin flaps, only the axillary drain will be considered
boolean
C0024881 (UMLS CUI [1])
C0180499 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
Excision of axillary lymph nodes Previous | Sentinel Lymph Node Biopsy Previous
Item
prior axillary dissection (except prior sentinel node procedure)
boolean
C0193867 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0796693 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Previous Therapeutic radiology procedure Axilla
Item
prior axillary radiotherapy
boolean
C0205156 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0004454 (UMLS CUI [1,3])
Mental disorders Compliance behavior Limited
Item
psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out qol forms
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Study Subject Participation Status | Therapeutic procedure Investigational New Drugs
Item
concurrent treatment with other experimental drugs or treatment in a clinical trial within 30 days prior to trial entry
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])