ID

34994

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02249208

Nyckelord

Versioner (1)
  1. 2019-02-07 2019-02-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 februari 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Breast Cancer NCT02249208

Engelsk

Eligibility Breast Cancer NCT02249208

1 Formulär  
Inclusion Criteria
Beskrivning

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
Beskrivning

Invasive carcinoma of breast Primary TNM Breast tumor staging

Datatyp

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
Beskrivning

Chemotherapy Neoadjuvant Completed | Chemotherapy Neoadjuvant Planned

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Excision of sentinel lymph node Quantity

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
t4 tumors, cn3 or cm1
Beskrivning

Malignant Neoplasms TNM clinical staging

Datatyp

boolean

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

Axilla Positive Ultrasonography | Status post Chemotherapy

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Chronic iron overload

Datatyp

boolean

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

Artificial cardiac pacemaker | Metallic device Chest wall

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Prisoners | Guardianship of Patient

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT02249208

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial