ID

38317

Description

Cryotherapy for Breast Cancer Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01671943

Link

https://clinicaltrials.gov/show/NCT01671943

Keywords

Versions (1)
  1. 10/9/19 10/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Carcinoma NCT01671943

English

Eligibility Breast Carcinoma NCT01671943

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. patients with contralateral disease will remain eligible. note: results of er, pr, her-2/neu must be obtained on pre-registration needle core biopsy material.
Description

Invasive Ductal Breast Carcinoma Unifocal Core needle biopsy | Disease Contralateral

Data type

boolean

Alias
UMLS CUI [1,1]
C1134719
UMLS CUI [1,2]
C0443337
UMLS CUI [1,3]
C1318309
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0441988
tumor size ≤ 2.0 cm in greatest diameter as measured by breast ultrasound, mri and mammogram. the largest dimension measured will be used to determine eligibility.
Description

Tumor size Longest Diameter Mammary Ultrasonography | Tumor size Longest Diameter MRI | Tumor size Longest Diameter Mammography

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0552406
UMLS CUI [1,3]
C0080264
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C0552406
UMLS CUI [2,3]
C0024485
UMLS CUI [3,1]
C0475440
UMLS CUI [3,2]
C0552406
UMLS CUI [3,3]
C0024671
tumor enhancement on mri
Description

Neoplasm Contrast-enhanced MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1707501
tumor with <25% intraductal components in the aggregate.
Description

Intraductal tumor configuration Component Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1276434
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0439165
non-pregnant and non-lactating patients. patients of childbearing potential must have a negative serum or urine pregnancy test. note: peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430057
adequate breast size for safe cryoablation. patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation. note: the minimal distance of tumor margins from the breast skin should be analogous to the surgical margins of a lumpectomy.
Description

Breast size Adequate Cryosurgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0425782
UMLS CUI [1,2]
C0205411
UMLS CUI [1,3]
C0010408
Exclusion Criteria
Description

Exclusion Criteria

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

Multifocal breast carcinoma Ipsilateral | Multicentric Breast Carcinoma Ipsilateral | Calcifications Multifocal | DCIS Excessive

Data type

boolean

Alias
UMLS CUI [1,1]
C2986662
UMLS CUI [1,2]
C0441989
UMLS CUI [2,1]
C2986664
UMLS CUI [2,2]
C0441989
UMLS CUI [3,1]
C0175895
UMLS CUI [3,2]
C0205292
UMLS CUI [4,1]
C0007124
UMLS CUI [4,2]
C0442802
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 Rotational | Incisional biopsy En Bloc | Segmental Mastectomy | Diagnosis Breast Carcinoma | Treatment Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1710607
UMLS CUI [1,2]
C0445237
UMLS CUI [2,1]
C0184922
UMLS CUI [2,2]
C1516835
UMLS CUI [3]
C0024885
UMLS CUI [4,1]
C0011900
UMLS CUI [4,2]
C0678222
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0678222
prior or planned neoadjuvant chemotherapy for breast cancer.
Description

Neoadjuvant Chemotherapy Breast Carcinoma | Neoadjuvant Chemotherapy Planned Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [2,3]
C1301732
UMLS CUI [2,4]
C0678222
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 Carcinoma NCT01671943

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive Ductal Breast Carcinoma Unifocal Core needle biopsy | Disease Contralateral
Item
unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. patients with contralateral disease will remain eligible. note: results of er, pr, her-2/neu must be obtained on pre-registration needle core biopsy material.
boolean
C1134719 (UMLS CUI [1,1])
C0443337 (UMLS CUI [1,2])
C1318309 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
Tumor size Longest Diameter Mammary Ultrasonography | Tumor size Longest Diameter MRI | Tumor size Longest Diameter Mammography
Item
tumor size ≤ 2.0 cm in greatest diameter as measured by breast ultrasound, mri and mammogram. the largest dimension measured will be used to determine eligibility.
boolean
C0475440 (UMLS CUI [1,1])
C0552406 (UMLS CUI [1,2])
C0080264 (UMLS CUI [1,3])
C0475440 (UMLS CUI [2,1])
C0552406 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0475440 (UMLS CUI [3,1])
C0552406 (UMLS CUI [3,2])
C0024671 (UMLS CUI [3,3])
Neoplasm Contrast-enhanced MRI
Item
tumor enhancement on mri
boolean
C0027651 (UMLS CUI [1,1])
C1707501 (UMLS CUI [1,2])
Intraductal tumor configuration Component Percentage
Item
tumor with <25% intraductal components in the aggregate.
boolean
C1276434 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
non-pregnant and non-lactating patients. patients of childbearing potential must have a negative serum or urine pregnancy test. note: peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
Breast size Adequate Cryosurgery
Item
adequate breast size for safe cryoablation. patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation. note: the minimal distance of tumor margins from the breast skin should be analogous to the surgical margins of a lumpectomy.
boolean
C0425782 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0010408 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Multifocal breast carcinoma Ipsilateral | Multicentric Breast Carcinoma Ipsilateral | Calcifications Multifocal | DCIS Excessive
Item
patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive dcis.
boolean
C2986662 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C2986664 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])
C0175895 (UMLS CUI [3,1])
C0205292 (UMLS CUI [3,2])
C0007124 (UMLS CUI [4,1])
C0442802 (UMLS CUI [4,2])
Vacuum-Assisted Biopsy Rotational | Incisional biopsy En Bloc | Segmental Mastectomy | Diagnosis Breast Carcinoma | Treatment Breast Carcinoma
Item
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 [1,1])
C0445237 (UMLS CUI [1,2])
C0184922 (UMLS CUI [2,1])
C1516835 (UMLS CUI [2,2])
C0024885 (UMLS CUI [3])
C0011900 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0678222 (UMLS CUI [5,2])
Neoadjuvant Chemotherapy Breast Carcinoma | Neoadjuvant Chemotherapy Planned Breast Carcinoma
Item
prior or planned neoadjuvant chemotherapy for breast cancer.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0678222 (UMLS CUI [2,4])
Thrombocytopenia | Abnormality of coagulation
Item
patients with thrombocytopenia and or any other coagulation abnormality
boolean
C0040034 (UMLS CUI [1])
C1846821 (UMLS CUI [2])
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