ID

14810

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02340858

Stichworte

Versionen (2)
  1. 29.04.16 29.04.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

29. April 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02340858

Englisch

Eligibility Breast Cancer NCT02340858

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Gender | Age | Breast Carcinoma unresectable | Unwilling Mastectomy Glandular

Datentyp

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.
Beschreibung

Breast Carcinoma | Core needle biopsy of breast

Datentyp

boolean

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

Menopausal Status

Datentyp

boolean

Alias
UMLS CUI [1]
C1513126
4. no history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Neoplasms Enhancement | Magnetic Resonance Imaging Pre-study

Datentyp

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.
Beschreibung

Intraductal breast neoplasm

Datentyp

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,
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

Tumor tissue sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0475358
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Neoadjuvant Therapy Chemotherapy Regimen Breast Carcinoma

Datentyp

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
Beschreibung

Thrombocytopenia | Abnormality of coagulation

Datentyp

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C1846821
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Ähnliche Modelle

Eligibility Breast Cancer NCT02340858

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
C1513126 (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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