Invasive carcinoma of breast Length
Item
1. subjects with an invasive breast cancer 1.5 cm or less
boolean
C0853879 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Ductal Breast Carcinoma Unifocal | Oestrogen receptor positive breast cancer | HER2 negative carcinoma of breast
Item
2. the breast cancer must be of ductal histology, unifocal, estrogen receptor positive and her2/neu negative.
boolean
C1527349 (UMLS CUI [1,1])
C0443337 (UMLS CUI [1,2])
C2938924 (UMLS CUI [2])
C2316304 (UMLS CUI [3])
Neoplasm Visible Ultrasonography | Excision Absent Primary Lesion
Item
3. the tumor must be visible by ultrasound and the subject must not have had prior surgical resection of the primary lesion.
boolean
C0027651 (UMLS CUI [1,1])
C0205379 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
C0728940 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1402294 (UMLS CUI [2,3])
Clip placement Tissue Marker Breast Carcinoma | Clip placement prior to Cold Therapy
Item
4. a clip marking the breast cancer must have been placed at the time of initial diagnosis or will be placed prior to cryotherapy.
boolean
C4489472 (UMLS CUI [1,1])
C0183956 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C4489472 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0010412 (UMLS CUI [2,3])
Breast Carcinoma Amenable Cryosurgery | Breast Carcinoma Visible Ultrasonography | Breast Carcinoma Separate Skin | Breast Carcinoma Separate Chest wall
Item
5. the breast cancer must be amenable to cryoablation (visible by ultrasound and more than 2 mm from skin or chest wall).
boolean
C0678222 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0010408 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C0205379 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
C0678222 (UMLS CUI [3,1])
C0443299 (UMLS CUI [3,2])
C1123023 (UMLS CUI [3,3])
C0678222 (UMLS CUI [4,1])
C0443299 (UMLS CUI [4,2])
C0205076 (UMLS CUI [4,3])
Neoplasm Metastasis | Excision Primary tumor
Item
6. subjects with metastatic disease at diagnosis who elect to have their primary tumor excised are eligible for enrollment.
boolean
C0027627 (UMLS CUI [1])
C0728940 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
Breast implants | Lesion With distance Implants
Item
7. for subjects with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion with not contact or jeopardize the implant.
boolean
C0179412 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C2979906 (UMLS CUI [2,2])
C0021102 (UMLS CUI [2,3])
Informed Consent
Item
8. subjects must be able to provide consent.
boolean
C0021430 (UMLS CUI [1])
Breast cancer, lobular | Breast Carcinoma Lymph-vascular invasion | Breast Carcinoma Extensive intraductal component
Item
1. subjects with breast cancers of lobular histology, with lymph vascular invasion or extensive intraductal component will be excluded.
boolean
C3549742 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C2924460 (UMLS CUI [2,2])
C0678222 (UMLS CUI [3,1])
C1882485 (UMLS CUI [3,2])
Multicentric Breast Carcinoma | Multifocal breast carcinoma
Item
2. subjects with multi-centric or multi-focal breast cancers
boolean
C2986664 (UMLS CUI [1])
C2986662 (UMLS CUI [2])
Breast Carcinoma Invasion Skin | Breast Carcinoma Skin Tethering
Item
3. subjects with breast cancers that have invaded skin or have significant skin tethering (assessed clinically).
boolean
C0678222 (UMLS CUI [1,1])
C1269955 (UMLS CUI [1,2])
C1123023 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0577538 (UMLS CUI [2,3])
Chemotherapy | Neoadjuvant Chemotherapy
Item
4. subjects receiving chemotherapy within one year or undergoing neoadjuvant chemotherapy are excluded.
boolean
C0392920 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
Neoplasm Metastasis | Exception Operative Surgical Procedure Primary Lesion
Item
5. subjects with metastatic disease at diagnosis will be excluded unless they elect definitive surgical therapy for their primary lesion.
boolean
C0027627 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C1402294 (UMLS CUI [2,3])
Breast Carcinoma Inappropriate Cryosurgery | Lesion Invisible Ultrasonography | Lesion Against Chest wall | Lesion Nearby Skin
Item
6. subjects with breast cancers not amenable to cryoablation (lesions not visible by ultrasound, against the chest wall or within 2 mm of skin) will be excluded.
boolean
C0678222 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0010408 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0205398 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
C0221198 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0205076 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C1706276 (UMLS CUI [4,2])
C1123023 (UMLS CUI [4,3])
Cancer Other
Item
7. subjects diagnosed with another malignancy in the preceding 5 years will be excluded.
boolean
C1707251 (UMLS CUI [1])
Synchronous Bilateral Breast Carcinoma
Item
8. subjects diagnosed with simultaneous bilateral breast cancer.
boolean
C1515107 (UMLS CUI [1])
Therapeutic immunosuppression | Steroids Oral
Item
9. subjects receiving immunosuppressive therapy within 6 months including oral steroids will be excluded.
boolean
C0021079 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])