ID

34994

Beschreibung

Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast Cancer Patients After Neoadjuvant Treatment.; ODM derived from: https://clinicaltrials.gov/show/NCT02249208

Link

https://clinicaltrials.gov/show/NCT02249208

Stichworte

Versionen (1)
  1. 07.02.19 07.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Februar 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02249208

Englisch

Eligibility Breast Cancer NCT02249208

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven primary invasive breast cancer with clinical stage t1 through t3, n1 through n2, m0 according to the american joint committee on cancer (ajcc) cancer staging manual, seventh edition
Beschreibung

Invasive carcinoma of breast Primary TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0474926
completed or were planning to undergo neoadjuvant chemotherapy
Beschreibung

Chemotherapy Neoadjuvant Completed | Chemotherapy Neoadjuvant Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C1301732
prechemotherapy axillary nodal disease confirmed by fine-needle aspiration or core-needle biopsy
Beschreibung

Axillary lymph nodes Disease Before Chemotherapy | Fine needle aspiration | Core needle biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0392920
UMLS CUI [2]
C1510483
UMLS CUI [3]
C1318309
the axilla is clinically and radiologically (by ultrasound) negative (ycn0) postchemotherapy and before surgery
Beschreibung

Axilla Negative Ultrasonography | Status post Chemotherapy | Status pre- Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004454
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0041618
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0392920
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0543467
removal of at least two slns
Beschreibung

Excision of sentinel lymph node Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2733271
UMLS CUI [1,2]
C1265611
signed informed consent from each patient before study entry
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
t4 tumors, cn3 or cm1
Beschreibung

Malignant Neoplasms TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3258246
the axilla is clinically and radiologically (by ultrasound) positive (ycn1) postchemotherapy
Beschreibung

Axilla Positive Ultrasonography | Status post Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004454
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0041618
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0392920
intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to vital blue dye or radioactive product.
Beschreibung

Intolerance to Iron-Dextran Compound | Hypersensitivity Iron-Dextran Compound | Intolerance to Ferumoxides | Hypersensitivity Ferumoxides | Other Coding | Intolerance to Radioactive agent | Hypersensitivity Radioactive agent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0022092
UMLS CUI [1,3]
C1706082
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0022092
UMLS CUI [2,3]
C1706082
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0246249
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0246249
UMLS CUI [5]
C3846158
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0279165
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0279165
chronic iron overload
Beschreibung

Chronic iron overload

Datentyp

boolean

Alias
UMLS CUI [1]
C1739382
pacemaker or other metallic implantable device in the chest wall
Beschreibung

Artificial cardiac pacemaker | Metallic device Chest wall

Datentyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2,1]
C3693688
UMLS CUI [2,2]
C0205076
failure to submit to medical study for geographical, social or psychological
Beschreibung

Submission Clinical Trial failed | Etiology Geographic Factors | Etiology Social factor | Etiology Psychological Factors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515022
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0017444
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0337460
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0033898
patient deprived of liberty or under guardianship
Beschreibung

Prisoners | Guardianship of Patient

Datentyp

boolean

Alias
UMLS CUI [1]
C0033167
UMLS CUI [2,1]
C0680611
UMLS CUI [2,2]
C0030705
pregnant or lactating
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Breast Cancer NCT02249208

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Primary TNM Breast tumor staging
Item
histologically proven primary invasive breast cancer with clinical stage t1 through t3, n1 through n2, m0 according to the american joint committee on cancer (ajcc) cancer staging manual, seventh edition
boolean
C0853879 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Chemotherapy Neoadjuvant Completed | Chemotherapy Neoadjuvant Planned
Item
completed or were planning to undergo neoadjuvant chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Axillary lymph nodes Disease Before Chemotherapy | Fine needle aspiration | Core needle biopsy
Item
prechemotherapy axillary nodal disease confirmed by fine-needle aspiration or core-needle biopsy
boolean
C0729594 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,4])
C1510483 (UMLS CUI [2])
C1318309 (UMLS CUI [3])
Axilla Negative Ultrasonography | Status post Chemotherapy | Status pre- Operative Surgical Procedures
Item
the axilla is clinically and radiologically (by ultrasound) negative (ycn0) postchemotherapy and before surgery
boolean
C0004454 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Excision of sentinel lymph node Quantity
Item
removal of at least two slns
boolean
C2733271 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent from each patient before study entry
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms TNM clinical staging
Item
t4 tumors, cn3 or cm1
boolean
C0006826 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Axilla Positive Ultrasonography | Status post Chemotherapy
Item
the axilla is clinically and radiologically (by ultrasound) positive (ycn1) postchemotherapy
boolean
C0004454 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
Intolerance to Iron-Dextran Compound | Hypersensitivity Iron-Dextran Compound | Intolerance to Ferumoxides | Hypersensitivity Ferumoxides | Other Coding | Intolerance to Radioactive agent | Hypersensitivity Radioactive agent
Item
intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to vital blue dye or radioactive product.
boolean
C1744706 (UMLS CUI [1,1])
C0022092 (UMLS CUI [1,2])
C1706082 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0022092 (UMLS CUI [2,2])
C1706082 (UMLS CUI [2,3])
C1744706 (UMLS CUI [3,1])
C0246249 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0246249 (UMLS CUI [4,2])
C3846158 (UMLS CUI [5])
C1744706 (UMLS CUI [6,1])
C0279165 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0279165 (UMLS CUI [7,2])
Chronic iron overload
Item
chronic iron overload
boolean
C1739382 (UMLS CUI [1])
Artificial cardiac pacemaker | Metallic device Chest wall
Item
pacemaker or other metallic implantable device in the chest wall
boolean
C0030163 (UMLS CUI [1])
C3693688 (UMLS CUI [2,1])
C0205076 (UMLS CUI [2,2])
Submission Clinical Trial failed | Etiology Geographic Factors | Etiology Social factor | Etiology Psychological Factors
Item
failure to submit to medical study for geographical, social or psychological
boolean
C1515022 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0017444 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0337460 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0033898 (UMLS CUI [4,2])
Prisoners | Guardianship of Patient
Item
patient deprived of liberty or under guardianship
boolean
C0033167 (UMLS CUI [1])
C0680611 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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