ID

34948

Descripción

Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy; ODM derived from: https://clinicaltrials.gov/show/NCT02027818

Link

https://clinicaltrials.gov/show/NCT02027818

Palabras clave

Versiones (1)
  1. 5/2/19 5/2/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de febrero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02027818

Inglés

Eligibility Breast Cancer NCT02027818

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with sln selective lymphadenectomy, or with complete axillary node dissection,
Descripción

Malignant neoplasm of breast | Patients Appropriate Tumorectomy | Sentinel lymphadenectomy | Excision of axillary lymph nodes Complete

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006142
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C3267186
UMLS CUI [3]
C2363825
UMLS CUI [4,1]
C0193867
UMLS CUI [4,2]
C0205197
informed consent form signed.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of mammary cancer established by "gross" biopsy,
Descripción

Malignant neoplasm of breast Biopsy Gross

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006142
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0439806
age less than18 years old.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
inability to give informed consent.
Descripción

Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
history of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Ingredient | Iodine allergy | Shellfish allergy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1550600
UMLS CUI [3]
C0571818
UMLS CUI [4]
C0577625
apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
Descripción

Hyperthyroidism apparent | Thyroid Adenoma Autonomous | Autonomy of thyroid gland Unifocal | Autonomy of thyroid gland Multifocal | Autonomy of thyroid gland Disseminated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0750489
UMLS CUI [2,1]
C0151468
UMLS CUI [2,2]
C0342136
UMLS CUI [3,1]
C1536123
UMLS CUI [3,2]
C0443337
UMLS CUI [4,1]
C1536123
UMLS CUI [4,2]
C0205292
UMLS CUI [5,1]
C1536123
UMLS CUI [5,2]
C0205221
documented coronary disease.
Descripción

Coronary Artery Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1956346
advanced renal impairment (creatinine > 1,5mg/dl).
Descripción

Renal Insufficiency Advanced | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0201976
during the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of icg (i.e. anticonvulsants, haloperidol and heparin).
Descripción

Anticonvulsants | Haloperidol | Heparin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003286
UMLS CUI [2]
C0018546
UMLS CUI [3]
C0019134
pregnancy, breastfeeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT02027818

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Malignant neoplasm of breast | Patients Appropriate Tumorectomy | Sentinel lymphadenectomy | Excision of axillary lymph nodes Complete
Item
patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with sln selective lymphadenectomy, or with complete axillary node dissection,
boolean
C0006142 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C3267186 (UMLS CUI [2,3])
C2363825 (UMLS CUI [3])
C0193867 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
Informed Consent
Item
informed consent form signed.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant neoplasm of breast Biopsy Gross
Item
diagnosis of mammary cancer established by "gross" biopsy,
boolean
C0006142 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0439806 (UMLS CUI [1,3])
Age
Item
age less than18 years old.
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable
Item
inability to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Ingredient | Iodine allergy | Shellfish allergy
Item
history of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
C0571818 (UMLS CUI [3])
C0577625 (UMLS CUI [4])
Hyperthyroidism apparent | Thyroid Adenoma Autonomous | Autonomy of thyroid gland Unifocal | Autonomy of thyroid gland Multifocal | Autonomy of thyroid gland Disseminated
Item
apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
boolean
C0020550 (UMLS CUI [1,1])
C0750489 (UMLS CUI [1,2])
C0151468 (UMLS CUI [2,1])
C0342136 (UMLS CUI [2,2])
C1536123 (UMLS CUI [3,1])
C0443337 (UMLS CUI [3,2])
C1536123 (UMLS CUI [4,1])
C0205292 (UMLS CUI [4,2])
C1536123 (UMLS CUI [5,1])
C0205221 (UMLS CUI [5,2])
Coronary Artery Disease
Item
documented coronary disease.
boolean
C1956346 (UMLS CUI [1])
Renal Insufficiency Advanced | Creatinine measurement, serum
Item
advanced renal impairment (creatinine > 1,5mg/dl).
boolean
C1565489 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Anticonvulsants | Haloperidol | Heparin
Item
during the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of icg (i.e. anticonvulsants, haloperidol and heparin).
boolean
C0003286 (UMLS CUI [1])
C0018546 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnancy, breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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