ID

43763

Description

Percutaneous Irreversible Electroportion for Unresectable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02340858

Link

https://clinicaltrials.gov/show/NCT02340858

Keywords

Versions (2)
  1. 4/29/16 4/29/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02340858

English

Eligibility Breast Cancer NCT02340858

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women 18 years or older with unresectable breast cancer, not amenable/willing to adenomammectomy.
Description

Gender | Age | Breast Carcinoma unresectable | Unwilling Mastectomy Glandular

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C1519810
UMLS CUI [4,1]
C0558080
UMLS CUI [4,2]
C0024881
UMLS CUI [4,3]
C0225353
2. breast carcinoma diagnosed by core needle biopsy.
Description

Breast Carcinoma | Core needle biopsy of breast

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0191853
3. any menopausal status.
Description

Menopausal Status

Data type

boolean

Alias
UMLS CUI [1]
C3829127
4. no history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer.
Description

En Bloc Surgical biopsy | Lumpectomy (breast cancer) | Diagnosis | Therapeutic procedure | Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1516835
UMLS CUI [1,2]
C0565118
UMLS CUI [2]
C0740370
UMLS CUI [3]
C0011900
UMLS CUI [4]
C0087111
UMLS CUI [5]
C0678222
5. tumor size ≤ 5.0 cm in greatest diameter. largest size measured by required scans (mammogram, ultrasound and mri) will be used to determine eligibility.
Description

Tumor size | Mammography | Ultrasonics (sound) | Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2]
C0024671
UMLS CUI [3]
C1456803
UMLS CUI [4]
C0024485
6. tumor enhancement on pre-study mri.
Description

Neoplasms Enhancement | Magnetic Resonance Imaging Pre-study

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2349975
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C1527048
7. tumor with < 25% intraductal components in the aggregate.
Description

Intraductal breast neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0948967
8. progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy,
Description

Tumor Progression | Adjuvant therapy | Advanced breast cancer | Carcinoma breast stage IV | Breast Cancer Therapeutic Procedure

Data type

boolean

Alias
UMLS CUI [1]
C0178874
UMLS CUI [2]
C0677850
UMLS CUI [3]
C3495917
UMLS CUI [4]
C0278488
UMLS CUI [5]
C1511300
9. non-pregnant and non-lactating. patients of childbearing potential must have a negative serum or urine pregnancy test.
Description

Pregnancy | Breast Feeding | Childbearing Potential | Serum pregnancy test negative | Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0430061
UMLS CUI [5]
C0430057
10. adequate breast size for safe ire. male breast cancer patients and female breast cancer patients with breasts too small to allow safe ire are not eligible as the minimal thickness of the breast tissue does not lend itself to ire. note: for patients with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion will not contact or jeopardize the implant.
Description

Breast size | Irreversible electroporation system | Carcinoma of Male Breast | Female Breast Carcinoma | Breast Prosthesis, Internal

Data type

boolean

Alias
UMLS CUI [1]
C0425782
UMLS CUI [2]
C3876171
UMLS CUI [3]
C0238033
UMLS CUI [4]
C0007104
UMLS CUI [5]
C0179412
11. adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
Description

body system or organ function | Bone Marrow Function | Toxic effect | Prior Therapy | history of prior surgery

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0542341
UMLS CUI [3]
C0600688
UMLS CUI [4]
C1514463
UMLS CUI [5]
C0744961
12. patient must agree to provide tumor tissue from metastatic tissue at baseline.
Description

Tumor tissue sample

Data type

boolean

Alias
UMLS CUI [1]
C0475358
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive dcis.
Description

Multifocal breast carcinoma | Multicentric Breast Carcinoma | Calcification of breast | Noninfiltrating Intraductal Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2986662
UMLS CUI [2]
C2986664
UMLS CUI [3]
C0587094
UMLS CUI [4]
C0007124
2. history of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
Description

Vacuum-Assisted Biopsy | En Bloc Surgical biopsy | Lumpectomy (breast cancer) | Diagnosis | Therapeutic procedure | Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1710607
UMLS CUI [2,1]
C1516835
UMLS CUI [2,2]
C0565118
UMLS CUI [3]
C0740370
UMLS CUI [4]
C0011900
UMLS CUI [5]
C0087111
UMLS CUI [6]
C0678222
3. prior or planned neoadjuvant chemotherapy for breast cancer.
Description

Neoadjuvant Therapy Chemotherapy Regimen Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0678222
4. patients with thrombocytopenia and or any other coagulation abnormality
Description

Thrombocytopenia | Abnormality of coagulation

Data type

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C1846821
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Similar models

Eligibility Breast Cancer NCT02340858

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Breast Carcinoma unresectable | Unwilling Mastectomy Glandular
Item
1. women 18 years or older with unresectable breast cancer, not amenable/willing to adenomammectomy.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C0558080 (UMLS CUI [4,1])
C0024881 (UMLS CUI [4,2])
C0225353 (UMLS CUI [4,3])
Breast Carcinoma | Core needle biopsy of breast
Item
2. breast carcinoma diagnosed by core needle biopsy.
boolean
C0678222 (UMLS CUI [1])
C0191853 (UMLS CUI [2])
Menopausal Status
Item
3. any menopausal status.
boolean
C3829127 (UMLS CUI [1])
En Bloc Surgical biopsy | Lumpectomy (breast cancer) | Diagnosis | Therapeutic procedure | Breast Carcinoma
Item
4. no history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer.
boolean
C1516835 (UMLS CUI [1,1])
C0565118 (UMLS CUI [1,2])
C0740370 (UMLS CUI [2])
C0011900 (UMLS CUI [3])
C0087111 (UMLS CUI [4])
C0678222 (UMLS CUI [5])
Tumor size | Mammography | Ultrasonics (sound) | Magnetic Resonance Imaging
Item
5. tumor size ≤ 5.0 cm in greatest diameter. largest size measured by required scans (mammogram, ultrasound and mri) will be used to determine eligibility.
boolean
C0475440 (UMLS CUI [1])
C0024671 (UMLS CUI [2])
C1456803 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
Neoplasms Enhancement | Magnetic Resonance Imaging Pre-study
Item
6. tumor enhancement on pre-study mri.
boolean
C0027651 (UMLS CUI [1,1])
C2349975 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C1527048 (UMLS CUI [2,2])
Intraductal breast neoplasm
Item
7. tumor with < 25% intraductal components in the aggregate.
boolean
C0948967 (UMLS CUI [1])
Tumor Progression | Adjuvant therapy | Advanced breast cancer | Carcinoma breast stage IV | Breast Cancer Therapeutic Procedure
Item
8. progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy,
boolean
C0178874 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
C3495917 (UMLS CUI [3])
C0278488 (UMLS CUI [4])
C1511300 (UMLS CUI [5])
Pregnancy | Breast Feeding | Childbearing Potential | Serum pregnancy test negative | Urine pregnancy test negative
Item
9. non-pregnant and non-lactating. patients of childbearing potential must have a negative serum or urine pregnancy test.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0430061 (UMLS CUI [4])
C0430057 (UMLS CUI [5])
Breast size | Irreversible electroporation system | Carcinoma of Male Breast | Female Breast Carcinoma | Breast Prosthesis, Internal
Item
10. adequate breast size for safe ire. male breast cancer patients and female breast cancer patients with breasts too small to allow safe ire are not eligible as the minimal thickness of the breast tissue does not lend itself to ire. note: for patients with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion will not contact or jeopardize the implant.
boolean
C0425782 (UMLS CUI [1])
C3876171 (UMLS CUI [2])
C0238033 (UMLS CUI [3])
C0007104 (UMLS CUI [4])
C0179412 (UMLS CUI [5])
body system or organ function | Bone Marrow Function | Toxic effect | Prior Therapy | history of prior surgery
Item
11. adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0542341 (UMLS CUI [2,2])
C0600688 (UMLS CUI [3])
C1514463 (UMLS CUI [4])
C0744961 (UMLS CUI [5])
Tumor tissue sample
Item
12. patient must agree to provide tumor tissue from metastatic tissue at baseline.
boolean
C0475358 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Multifocal breast carcinoma | Multicentric Breast Carcinoma | Calcification of breast | Noninfiltrating Intraductal Carcinoma
Item
1. patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive dcis.
boolean
C2986662 (UMLS CUI [1])
C2986664 (UMLS CUI [2])
C0587094 (UMLS CUI [3])
C0007124 (UMLS CUI [4])
Vacuum-Assisted Biopsy | En Bloc Surgical biopsy | Lumpectomy (breast cancer) | Diagnosis | Therapeutic procedure | Breast Carcinoma
Item
2. history of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
boolean
C1710607 (UMLS CUI [1])
C1516835 (UMLS CUI [2,1])
C0565118 (UMLS CUI [2,2])
C0740370 (UMLS CUI [3])
C0011900 (UMLS CUI [4])
C0087111 (UMLS CUI [5])
C0678222 (UMLS CUI [6])
Neoadjuvant Therapy Chemotherapy Regimen Breast Carcinoma
Item
3. prior or planned neoadjuvant chemotherapy for breast cancer.
boolean
C0600558 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Thrombocytopenia | Abnormality of coagulation
Item
4. patients with thrombocytopenia and or any other coagulation abnormality
boolean
C0040034 (UMLS CUI [1])
C1846821 (UMLS CUI [2])
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