ID

38362

Description

Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy; ODM derived from: https://clinicaltrials.gov/show/NCT01827969

Link

https://clinicaltrials.gov/show/NCT01827969

Keywords

Versions (1)
  1. 10/12/19 10/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Tumor NCT01827969

English

Eligibility Breast Tumor NCT01827969

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
invasive breast carcinoma with histologically confirmed hormone receptor analysis, the grade of the tumor, the expression of her-2.
Description

Invasive carcinoma of breast | Endocrine receptor assay | Tumor grade | HER2 expression

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0523374
UMLS CUI [3]
C0475753
UMLS CUI [4,1]
C0069515
UMLS CUI [4,2]
C0597360
lesion classified t1-t2-t3 unifocal or multifocal with or without associated microcalcifications
Description

Lesion Unifocal TNM clinical staging | Lesion Multifocal TNM clinical staging | Microcalcification Present | Microcalcification Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0443337
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205292
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C0521174
UMLS CUI [3,2]
C0150312
UMLS CUI [4,1]
C0521174
UMLS CUI [4,2]
C0332197
lesion recognizable and identifiable in mri
Description

Lesion Identified MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205396
UMLS CUI [1,3]
C0024485
indication of mastectomy with or without axillary
Description

Indication Mastectomy | Axillary lymph nodes Involved | Axillary lymph nodes Uninvolved

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0024881
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C1314939
UMLS CUI [3,1]
C0729594
UMLS CUI [3,2]
C0205429
lesion located more than 10 mm from the skin, the nipple and pectoralis major
Description

Location of lesion | Distance Skin | Distance Nipple | Distance Pectoralis major

Data type

boolean

Alias
UMLS CUI [1]
C2184261
UMLS CUI [2,1]
C0012751
UMLS CUI [2,2]
C1123023
UMLS CUI [3,1]
C0012751
UMLS CUI [3,2]
C0028109
UMLS CUI [4,1]
C0012751
UMLS CUI [4,2]
C0585574
no cons-indication to mri (pacemaker)
Description

Medical contraindication Absent MRI | Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0024485
UMLS CUI [2]
C0030163
women whose age is ≥ 18 years
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
if premenopausal patient: patient contraceptives
Description

Premenopausal state Contraceptive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0009871
patient has signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
affiliation to a social security scheme
Description

Affiliation Social Security Program

Data type

boolean

Alias
UMLS CUI [1,1]
C1510825
UMLS CUI [1,2]
C0037435
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
tumor-td t4b classified or non-palpable lesion
Description

Neoplasm TNM clinical staging | Lesion Non-Palpable

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C4086626
if age <70 years: no indication of adjuvant chemotherapy and neoadjuvant
Description

Age | Indication Adjuvant Chemotherapy | Indication Neoadjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0085533
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C3665472
mri lesions have not been identified, located within 10 mm of the skin and pectoral muscle, greater than 25 mm diameter
Description

MRI Lesion Unidentified | Location Distance Skin | Location Distance Pectoralis major | Lesion Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205427
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0012751
UMLS CUI [2,3]
C1123023
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C0012751
UMLS CUI [3,3]
C0585574
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C1301886
inability to hold still in the prone position, arms extended, for 30 minutes
Description

Lacking Able to lie down Prone Position Quiet

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560841
UMLS CUI [1,3]
C0033422
UMLS CUI [1,4]
C0439654
contraindication to mri
Description

Medical contraindication MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
patient deprived of liberty and major subject of a measure of legal protection or unable to consent
Description

Patient Deprivation Freedom | Protection of patient Legal | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
UMLS CUI [2,1]
C0412786
UMLS CUI [2,2]
C1301860
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
patient participating in another interventional clinical trial within 30 days prior to baseline and during the trial.
Description

Study Subject Participation Status | Interventional Study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
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Similar models

Eligibility Breast Tumor NCT01827969

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Endocrine receptor assay | Tumor grade | HER2 expression
Item
invasive breast carcinoma with histologically confirmed hormone receptor analysis, the grade of the tumor, the expression of her-2.
boolean
C0853879 (UMLS CUI [1])
C0523374 (UMLS CUI [2])
C0475753 (UMLS CUI [3])
C0069515 (UMLS CUI [4,1])
C0597360 (UMLS CUI [4,2])
Lesion Unifocal TNM clinical staging | Lesion Multifocal TNM clinical staging | Microcalcification Present | Microcalcification Absent
Item
lesion classified t1-t2-t3 unifocal or multifocal with or without associated microcalcifications
boolean
C0221198 (UMLS CUI [1,1])
C0443337 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0205292 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0521174 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0521174 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Lesion Identified MRI
Item
lesion recognizable and identifiable in mri
boolean
C0221198 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Indication Mastectomy | Axillary lymph nodes Involved | Axillary lymph nodes Uninvolved
Item
indication of mastectomy with or without axillary
boolean
C3146298 (UMLS CUI [1,1])
C0024881 (UMLS CUI [1,2])
C0729594 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0729594 (UMLS CUI [3,1])
C0205429 (UMLS CUI [3,2])
Location of lesion | Distance Skin | Distance Nipple | Distance Pectoralis major
Item
lesion located more than 10 mm from the skin, the nipple and pectoralis major
boolean
C2184261 (UMLS CUI [1])
C0012751 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0012751 (UMLS CUI [3,1])
C0028109 (UMLS CUI [3,2])
C0012751 (UMLS CUI [4,1])
C0585574 (UMLS CUI [4,2])
Medical contraindication Absent MRI | Artificial cardiac pacemaker
Item
no cons-indication to mri (pacemaker)
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0030163 (UMLS CUI [2])
Gender | Age
Item
women whose age is ≥ 18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Premenopausal state Contraceptive Agents
Item
if premenopausal patient: patient contraceptives
boolean
C0232969 (UMLS CUI [1,1])
C0009871 (UMLS CUI [1,2])
Informed Consent
Item
patient has signed informed consent
boolean
C0021430 (UMLS CUI [1])
Affiliation Social Security Program
Item
affiliation to a social security scheme
boolean
C1510825 (UMLS CUI [1,1])
C0037435 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Neoplasm TNM clinical staging | Lesion Non-Palpable
Item
tumor-td t4b classified or non-palpable lesion
boolean
C0027651 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C4086626 (UMLS CUI [2,2])
Age | Indication Adjuvant Chemotherapy | Indication Neoadjuvant Chemotherapy
Item
if age <70 years: no indication of adjuvant chemotherapy and neoadjuvant
boolean
C0001779 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0085533 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C3665472 (UMLS CUI [3,3])
MRI Lesion Unidentified | Location Distance Skin | Location Distance Pectoralis major | Lesion Diameter
Item
mri lesions have not been identified, located within 10 mm of the skin and pectoral muscle, greater than 25 mm diameter
boolean
C0024485 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205427 (UMLS CUI [1,3])
C1515974 (UMLS CUI [2,1])
C0012751 (UMLS CUI [2,2])
C1123023 (UMLS CUI [2,3])
C1515974 (UMLS CUI [3,1])
C0012751 (UMLS CUI [3,2])
C0585574 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
Lacking Able to lie down Prone Position Quiet
Item
inability to hold still in the prone position, arms extended, for 30 minutes
boolean
C0332268 (UMLS CUI [1,1])
C0560841 (UMLS CUI [1,2])
C0033422 (UMLS CUI [1,3])
C0439654 (UMLS CUI [1,4])
Medical contraindication MRI
Item
contraindication to mri
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Patient Deprivation Freedom | Protection of patient Legal | Informed Consent Unable
Item
patient deprived of liberty and major subject of a measure of legal protection or unable to consent
boolean
C0030705 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
C0412786 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Study Subject Participation Status | Interventional Study
Item
patient participating in another interventional clinical trial within 30 days prior to baseline and during the trial.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
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