Disease TNM Breast tumor staging
Item
histologically confirmed disease (ajc classification): tis, t1, t2 (≤ 3.0 cm), n0, m0.
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Disease Multifocal Microscopic | Disease Diameter
Item
microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
boolean
C0012634 (UMLS CUI [1,1])
C0205292 (UMLS CUI [1,2])
C0205288 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
Negative Surgical Margins Post Operative Surgical Procedures
Item
negative surgical margins ( ≥ 0.2 cm) after final surgery.
boolean
C1709157 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Histology Lobular Infiltrating | DCIS Nuclear grade High | Magnetic resonance imaging of breast Patient need for | Localized disease TNM Breast tumor staging
Item
subjects with infiltrating lobular histologies or high nuclear grade dcis will be required to have breast mri scanning as part of the initial staging to verify localized disease.
boolean
C0344441 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0332448 (UMLS CUI [1,3])
C0007124 (UMLS CUI [2,1])
C1518435 (UMLS CUI [2,2])
C0205250 (UMLS CUI [2,3])
C0344104 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0277565 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
DCIS | MRI Before Lumpectomy
Item
subjects with dcis will be included in the study only if they had an mri prior to lumpectomy.
boolean
C0007124 (UMLS CUI [1])
C0024485 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0024885 (UMLS CUI [2,3])
Distant metastasis Suspected MRI Scan | Ultrasonography Patient need for | Biopsy Patient need for | Exclusion Disease Multifocal | Exclusion Disease Multicentric
Item
findings on mri scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease.
boolean
C1269798 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0917711 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C2828389 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0205292 (UMLS CUI [4,3])
C2828389 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0439743 (UMLS CUI [5,3])
Calcifications Malignant Mammography | Mammography Repeat Post Operative Surgical Procedures | Excision Calcifications Malignant
Item
subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.
boolean
C0006660 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C0024671 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0543467 (UMLS CUI [2,4])
C0728940 (UMLS CUI [3,1])
C0006660 (UMLS CUI [3,2])
C0205282 (UMLS CUI [3,3])
Protocol Compliance | Clinical Trial Eligibility Criteria Study Protocol
Item
willing to complete additional screening requirements and meet eligibility criteria as defined in protocol sec. 4.4.
boolean
C0525058 (UMLS CUI [1])
C1516637 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Placement Fiducial Markers | Radiotherapy, Image-Guided
Item
successful placement of fiducial markers for igrt requiring nonmigrating fiducials.
boolean
C0441587 (UMLS CUI [1,1])
C2826325 (UMLS CUI [1,2])
C3179062 (UMLS CUI [2])
PTV Breast Ipsilateral Ratio
Item
ptv to ipsilateral breast ratio (ibr) ≤ 25 %.
boolean
C0454199 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0456603 (UMLS CUI [1,4])
Therapeutic radiology procedure Anticipated | Lumpectomy | Reexcision Surgical margins
Item
radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.
boolean
C1522449 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0024885 (UMLS CUI [2])
C0184913 (UMLS CUI [3,1])
C0229985 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Collagen-vascular disease
Item
have collagen-vascular disease.
boolean
C0262428 (UMLS CUI [1])
Surgical margins Inadequate Post Operative Surgical Procedures
Item
inadequate surgical margins ( < 0.2 cm) after final surgery.
boolean
C0229985 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
Microcalcifications Malignant persistent | Microcalcifications Suspicious persistent
Item
subjects with persistent malignant/suspicious micro-calcifications.
boolean
C0521174 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C0521174 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0205322 (UMLS CUI [2,3])
Disease Multifocal Gross | Disease Microscopic Diameter
Item
gross multifocal disease and microscopic disease greater than 3.0 cm.
boolean
C0012634 (UMLS CUI [1,1])
C0205292 (UMLS CUI [1,2])
C0439806 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205288 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])