Breast Carcinoma Diameter Imaging Techniques | Breast Carcinoma Diameter Mammography | Breast Carcinoma Diameter Ultrasonography | Breast Carcinoma Diameter MRI | Operative Surgical Procedure Scheduled | Mastectomy | Lumpectomy of breast
Item
patients with a breast tumor size < 2 cm in diameter (as determined by means of conventional imaging techniques: mammography, ultrasound or mri) who are scheduled to receive operative intervention either by means of a mastectomy or lumpectomy.
boolean
C0678222 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0079595 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0024671 (UMLS CUI [2,3])
C0678222 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])
C0678222 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
C0543467 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])
C0024881 (UMLS CUI [6])
C0851238 (UMLS CUI [7])
Breast Carcinoma Histology
Item
histologically proven breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-2 (see: appendix b)
boolean
C1298650 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent (approved by the institutional review board [irb]/
boolean
C0021430 (UMLS CUI [1])
ID.6
Item
independent ethics committee [iec]) obtained prior to any study specific screening procedures.
boolean
Protocol Compliance
Item
able to comply with the protocol.
boolean
C0525058 (UMLS CUI [1])
Invasive cancer Affecting Protocol Compliance | Condition Affecting Protocol Compliance | Invasive cancer Affecting Interpretation Research results | Condition Affecting Interpretation Research results
Item
other invasive malignancy or condition which could affect compliance with the protocol or interpretation of results.
boolean
C0677898 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0677898 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Premenopausal state Pregnancy test negative
Item
pregnant or lactating women. documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Prior radiation therapy Area Involved
Item
prior radiotherapy on the involved area.
boolean
C0279134 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Major surgery
Item
major surgery within 28 days before the initiation of the study.
boolean
C0679637 (UMLS CUI [1])
Cardiovascular Disease
Item
clinically significant cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
Allergic Reaction Immunoglobulins | Hypersensitivity Immunoglobulins
Item
prior allergic reaction to immunoglobulins or immunoglobulin allergy.
boolean
C1527304 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0021027 (UMLS CUI [2,2])