ID

13645

Description

Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01388777

Link

https://clinicaltrials.gov/show/NCT01388777

Keywords

Versions (1)
  1. 2/22/16 2/22/16 -
Uploaded on

February 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01388777

English

Eligibility Breast Cancer NCT01388777

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. note: patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or dcis with microinvasion are not eligible. patients with contralateral disease will remain eligible.
Description

invasive ductal breast carcinoma; core needle biopsy breast

Data type

boolean

Alias
UMLS CUI [1]
C1134719
UMLS CUI [2]
C0191853
2. neoadjuvant chemotherapy or hormonal therapy for the index tumor is required.
Description

neoadjuvant chemotherapy; hormonal therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [2]
C0279025
3. residual tumor size </= 2.0 cm in greatest diameter. specifically, the tumor must measure </= 2.0 cm in the axis parallel to the treatment probe and </= 1.5 cm in the axis anti-parallel to the treatment probe. largest size measured by mammogram, ultrasound or mri will be used to determine eligibility.
Description

tumor size residual; mammogram; ultrasound

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1609982
UMLS CUI [2]
C0024671
UMLS CUI [3]
C0041618
4. tumor enhancement on pre-registration mri.
Description

MRI

Data type

boolean

Alias
UMLS CUI [1]
C0024485
5. tumor with <25% intraductal components in the aggregate.
Description

aggregate; Ductal Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0205418
UMLS CUI [2]
C1176475
6. adequate breast size for safe cryoablation. male breast cancer patients and female breast cancer 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.
Description

cryoablation

Data type

boolean

Alias
UMLS CUI [1]
C0010408
7. patients with prior in-situ or invasive breast carcinomas are eligible if the prior carcinomas occurred in the contralateral breast. patients with prior in-situ or invasive carcinomas of the ipsilateral breast are not eligible.
Description

invasive breast carcinomas; Carcinoma in Situ

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0007099
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. note: prior rotational and/or vacuum-assisted core biopsies are permitted if no significant distortion is seen on imaging that could obscure visualization and detection of residual disease on mri, or visualization of cancer on ultrasound for cryoablation procedure.
Description

lumpectomy; Core needle biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0740370
UMLS CUI [2]
C1318309
2. pregnant and/or lactating. 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

Contraception status; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C2828358
3. patient has contra-indication to an mri examination, such as clips/prostheses/implants that are not mri compatible, or compromised renal function, with a measured or calculated glomerular filtration rate of 60ml/min/1.73m^2
Description

contraindication MRI; implants; glomerular filtration rate

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0021102
UMLS CUI [3]
C0017654
4. patients less than 18 years of age will not be included in this study.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Breast Cancer NCT01388777

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
invasive ductal breast carcinoma; core needle biopsy breast
Item
1. unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. note: patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or dcis with microinvasion are not eligible. patients with contralateral disease will remain eligible.
boolean
C1134719 (UMLS CUI [1])
C0191853 (UMLS CUI [2])
neoadjuvant chemotherapy; hormonal therapy
Item
2. neoadjuvant chemotherapy or hormonal therapy for the index tumor is required.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2])
tumor size residual; mammogram; ultrasound
Item
3. residual tumor size </= 2.0 cm in greatest diameter. specifically, the tumor must measure </= 2.0 cm in the axis parallel to the treatment probe and </= 1.5 cm in the axis anti-parallel to the treatment probe. largest size measured by mammogram, ultrasound or mri will be used to determine eligibility.
boolean
C0475440 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C0024671 (UMLS CUI [2])
C0041618 (UMLS CUI [3])
MRI
Item
4. tumor enhancement on pre-registration mri.
boolean
C0024485 (UMLS CUI [1])
aggregate; Ductal Carcinoma
Item
5. tumor with <25% intraductal components in the aggregate.
boolean
C0205418 (UMLS CUI [1])
C1176475 (UMLS CUI [2])
cryoablation
Item
6. adequate breast size for safe cryoablation. male breast cancer patients and female breast cancer 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.
boolean
C0010408 (UMLS CUI [1])
invasive breast carcinomas; Carcinoma in Situ
Item
7. patients with prior in-situ or invasive breast carcinomas are eligible if the prior carcinomas occurred in the contralateral breast. patients with prior in-situ or invasive carcinomas of the ipsilateral breast are not eligible.
boolean
C0853879 (UMLS CUI [1])
C0007099 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
lumpectomy; Core needle biopsy
Item
1. history of open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. note: prior rotational and/or vacuum-assisted core biopsies are permitted if no significant distortion is seen on imaging that could obscure visualization and detection of residual disease on mri, or visualization of cancer on ultrasound for cryoablation procedure.
boolean
C0740370 (UMLS CUI [1])
C1318309 (UMLS CUI [2])
Contraception status; lactating
Item
2. pregnant and/or lactating. 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
C0420837 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
contraindication MRI; implants; glomerular filtration rate
Item
3. patient has contra-indication to an mri examination, such as clips/prostheses/implants that are not mri compatible, or compromised renal function, with a measured or calculated glomerular filtration rate of 60ml/min/1.73m^2
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2])
C0017654 (UMLS CUI [3])
age
Item
4. patients less than 18 years of age will not be included in this study.
boolean
C0001779 (UMLS CUI [1])
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