ID

35078

Description

Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy; ODM derived from: https://clinicaltrials.gov/show/NCT02432118

Link

https://clinicaltrials.gov/show/NCT02432118

Keywords

Versions (1)
  1. 2/14/19 2/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasm NCT02432118

English

Eligibility Breast Neoplasm NCT02432118

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have had stereotactic or ultrasound-guided biopsy with marker placement
Description

Stereotactic Biopsy | Ultrasound guided biopsy | Fiducial marker placement

Data type

boolean

Alias
UMLS CUI [1]
C1711202
UMLS CUI [2]
C0456900
UMLS CUI [3]
C3888577
have a lesion or biopsy marker that is visible under ultrasound
Description

Lesion Visible Ultrasonography | Biopsy Marker Visible Ultrasonography

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205379
UMLS CUI [1,3]
C0041618
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0183956
UMLS CUI [2,3]
C0205379
UMLS CUI [2,4]
C0041618
have a surgical target =< 6 cm from the skin when lying supine
Description

Target Surgical | Distance Skin Supine Position

Data type

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0543467
UMLS CUI [2,1]
C0012751
UMLS CUI [2,2]
C1123023
UMLS CUI [2,3]
C0038846
have a discreet surgical target
Description

Target Surgical Discrete

Data type

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0443299
have a lesion in which the center/focal area is defined
Description

Lesion Center Determined | Lesion Focus Determined

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205099
UMLS CUI [1,3]
C0521095
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205234
UMLS CUI [2,3]
C0521095
have the ability to understand and the willingness to sign a written informed consent document
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
eastern cooperative oncology group (ecog)/karnofsky performance status will not be used as an inclusion criterion
Description

ECOG performance status Absent | Karnofsky Performance Status Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1520224
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0206065
UMLS CUI [2,2]
C0332197
ability to understand and the willingness to sign a written informed consent document
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
require more than one localization needle for localization of the surgical target (bracket localization)
Description

Localization needle Quantity | Localization Target Surgical | Bracket localization

Data type

boolean

Alias
UMLS CUI [1,1]
C0493790
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0475264
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0179407
UMLS CUI [3,2]
C0475264
have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast
Description

Incisional biopsy Breast Operative | Segmental Mastectomy Breast Operative | Mastectomy Breast Operative

Data type

boolean

Alias
UMLS CUI [1,1]
C0184922
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C1882154
UMLS CUI [2,1]
C0024885
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C1882154
UMLS CUI [3,1]
C0024881
UMLS CUI [3,2]
C0006141
UMLS CUI [3,3]
C1882154
have a prosthesis/implant in the operative breast
Description

Breast implant Breast Operative

Data type

boolean

Alias
UMLS CUI [1,1]
C0179412
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C1882154
have a cardiac pacemaker or defibrillator device
Description

Artificial cardiac pacemaker | Defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0180307
be contraindicated for surgery
Description

Medical contraindication Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0543467
be pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Breast Neoplasm NCT02432118

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Stereotactic Biopsy | Ultrasound guided biopsy | Fiducial marker placement
Item
have had stereotactic or ultrasound-guided biopsy with marker placement
boolean
C1711202 (UMLS CUI [1])
C0456900 (UMLS CUI [2])
C3888577 (UMLS CUI [3])
Lesion Visible Ultrasonography | Biopsy Marker Visible Ultrasonography
Item
have a lesion or biopsy marker that is visible under ultrasound
boolean
C0221198 (UMLS CUI [1,1])
C0205379 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C0183956 (UMLS CUI [2,2])
C0205379 (UMLS CUI [2,3])
C0041618 (UMLS CUI [2,4])
Target Surgical | Distance Skin Supine Position
Item
have a surgical target =< 6 cm from the skin when lying supine
boolean
C1521840 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0012751 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0038846 (UMLS CUI [2,3])
Target Surgical Discrete
Item
have a discreet surgical target
boolean
C1521840 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0443299 (UMLS CUI [1,3])
Lesion Center Determined | Lesion Focus Determined
Item
have a lesion in which the center/focal area is defined
boolean
C0221198 (UMLS CUI [1,1])
C0205099 (UMLS CUI [1,2])
C0521095 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0205234 (UMLS CUI [2,2])
C0521095 (UMLS CUI [2,3])
Informed Consent
Item
have the ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
ECOG performance status Absent | Karnofsky Performance Status Absent
Item
eastern cooperative oncology group (ecog)/karnofsky performance status will not be used as an inclusion criterion
boolean
C1520224 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0206065 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Localization needle Quantity | Localization Target Surgical | Bracket localization
Item
require more than one localization needle for localization of the surgical target (bracket localization)
boolean
C0493790 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0475264 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0179407 (UMLS CUI [3,1])
C0475264 (UMLS CUI [3,2])
Incisional biopsy Breast Operative | Segmental Mastectomy Breast Operative | Mastectomy Breast Operative
Item
have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast
boolean
C0184922 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C1882154 (UMLS CUI [1,3])
C0024885 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C1882154 (UMLS CUI [2,3])
C0024881 (UMLS CUI [3,1])
C0006141 (UMLS CUI [3,2])
C1882154 (UMLS CUI [3,3])
Breast implant Breast Operative
Item
have a prosthesis/implant in the operative breast
boolean
C0179412 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C1882154 (UMLS CUI [1,3])
Artificial cardiac pacemaker | Defibrillator
Item
have a cardiac pacemaker or defibrillator device
boolean
C0030163 (UMLS CUI [1])
C0180307 (UMLS CUI [2])
Medical contraindication Operative Surgical Procedures
Item
be contraindicated for surgery
boolean
C1301624 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Pregnancy
Item
be pregnant
boolean
C0032961 (UMLS CUI [1])
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