ID

38156

Beskrivning

Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT01856036

Länk

https://clinicaltrials.gov/show/NCT01856036

Nyckelord

Versioner (1)
  1. 2019-09-23 2019-09-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01856036

Engelsk

Eligibility Breast Cancer NCT01856036

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects with an invasive breast cancer 1.5 cm or less
Beskrivning

Invasive carcinoma of breast Length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1444754
2. the breast cancer must be of ductal histology, unifocal, estrogen receptor positive and her2/neu negative.
Beskrivning

Ductal Breast Carcinoma Unifocal | Oestrogen receptor positive breast cancer | HER2 negative carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527349
UMLS CUI [1,2]
C0443337
UMLS CUI [2]
C2938924
UMLS CUI [3]
C2316304
3. the tumor must be visible by ultrasound and the subject must not have had prior surgical resection of the primary lesion.
Beskrivning

Neoplasm Visible Ultrasonography | Excision Absent Primary Lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0205379
UMLS CUI [1,3]
C0041618
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1402294
4. a clip marking the breast cancer must have been placed at the time of initial diagnosis or will be placed prior to cryotherapy.
Beskrivning

Clip placement Tissue Marker Breast Carcinoma | Clip placement prior to Cold Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4489472
UMLS CUI [1,2]
C0183956
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C4489472
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0010412
5. the breast cancer must be amenable to cryoablation (visible by ultrasound and more than 2 mm from skin or chest wall).
Beskrivning

Breast Carcinoma Amenable Cryosurgery | Breast Carcinoma Visible Ultrasonography | Breast Carcinoma Separate Skin | Breast Carcinoma Separate Chest wall

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0010408
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0205379
UMLS CUI [2,3]
C0041618
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0443299
UMLS CUI [3,3]
C1123023
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C0443299
UMLS CUI [4,3]
C0205076
6. subjects with metastatic disease at diagnosis who elect to have their primary tumor excised are eligible for enrollment.
Beskrivning

Neoplasm Metastasis | Excision Primary tumor

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C0677930
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.
Beskrivning

Breast implants | Lesion With distance Implants

Datatyp

boolean

Alias
UMLS CUI [1]
C0179412
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C2979906
UMLS CUI [2,3]
C0021102
8. subjects must be able to provide consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects with breast cancers of lobular histology, with lymph vascular invasion or extensive intraductal component will be excluded.
Beskrivning

Breast cancer, lobular | Breast Carcinoma Lymph-vascular invasion | Breast Carcinoma Extensive intraductal component

Datatyp

boolean

Alias
UMLS CUI [1]
C3549742
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C2924460
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C1882485
2. subjects with multi-centric or multi-focal breast cancers
Beskrivning

Multicentric Breast Carcinoma | Multifocal breast carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2986664
UMLS CUI [2]
C2986662
3. subjects with breast cancers that have invaded skin or have significant skin tethering (assessed clinically).
Beskrivning

Breast Carcinoma Invasion Skin | Breast Carcinoma Skin Tethering

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1269955
UMLS CUI [1,3]
C1123023
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1123023
UMLS CUI [2,3]
C0577538
4. subjects receiving chemotherapy within one year or undergoing neoadjuvant chemotherapy are excluded.
Beskrivning

Chemotherapy | Neoadjuvant Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
5. subjects with metastatic disease at diagnosis will be excluded unless they elect definitive surgical therapy for their primary lesion.
Beskrivning

Neoplasm Metastasis | Exception Operative Surgical Procedure Primary Lesion

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C1402294
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.
Beskrivning

Breast Carcinoma Inappropriate Cryosurgery | Lesion Invisible Ultrasonography | Lesion Against Chest wall | Lesion Nearby Skin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0010408
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205398
UMLS CUI [2,3]
C0041618
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0205076
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C1706276
UMLS CUI [4,3]
C1123023
7. subjects diagnosed with another malignancy in the preceding 5 years will be excluded.
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
8. subjects diagnosed with simultaneous bilateral breast cancer.
Beskrivning

Synchronous Bilateral Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1515107
9. subjects receiving immunosuppressive therapy within 6 months including oral steroids will be excluded.
Beskrivning

Therapeutic immunosuppression | Steroids Oral

Datatyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C1527415
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Similar models

Eligibility Breast Cancer NCT01856036

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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