ID

38363

Beschrijving

Fluorescence-guided Resection in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01110954

Link

https://clinicaltrials.gov/show/NCT01110954

Trefwoorden

  1. 12-10-19 12-10-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 oktober 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Tumour NCT01110954

Eligibility Breast Tumour NCT01110954

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
caucasian female postmenopausal patients
Beschrijving

Caucasian | Gender | Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0043157
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0232970
patients with histologically confirmed primary palpable and nonpalpable breast cancer sized up to 5 cm (t1 - t2)
Beschrijving

Breast Carcinoma Palpable TNM Breast tumor staging | Breast Carcinoma Non-Palpable TNM Breast tumor staging | Tumor size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0522499
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C4086626
UMLS CUI [2,3]
C0474926
UMLS CUI [3]
C0475440
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
suspicious lymphogenic metastases (cn1-3)
Beschrijving

Neoplasm Metastasis Suspicious TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0750493
UMLS CUI [1,3]
C3258246
acute or chronic hepatic diseases
Beschrijving

Liver disease | Chronic liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0341439
manifest renal diseases with renal dysfunction
Beschrijving

Kidney Disease | Renal dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C3279454
relevant cardiac disease
Beschrijving

Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
preceding therapy of breast tumour under investigation
Beschrijving

Investigational Therapy Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C0678222
patients with multiple attempts of hook-wire placement in preparation of surgery
Beschrijving

Hooked wire Placement Attempt

Datatype

boolean

Alias
UMLS CUI [1,1]
C0441180
UMLS CUI [1,2]
C0589567
UMLS CUI [1,3]
C1516084
dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
Beschrijving

Dementia Interferes with Comprehension Study Protocol | Mental condition Interferes with Comprehension Study Protocol | Dementia Interferes with Informed Consent | Mental condition Interferes with Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0162340
UMLS CUI [2,4]
C2348563
UMLS CUI [3,1]
C0497327
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0021430
simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Breast Tumour NCT01110954

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Caucasian | Gender | Postmenopausal state
Item
caucasian female postmenopausal patients
boolean
C0043157 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Breast Carcinoma Palpable TNM Breast tumor staging | Breast Carcinoma Non-Palpable TNM Breast tumor staging | Tumor size
Item
patients with histologically confirmed primary palpable and nonpalpable breast cancer sized up to 5 cm (t1 - t2)
boolean
C0678222 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C4086626 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0475440 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Suspicious TNM clinical staging
Item
suspicious lymphogenic metastases (cn1-3)
boolean
C0027627 (UMLS CUI [1,1])
C0750493 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Liver disease | Chronic liver disease
Item
acute or chronic hepatic diseases
boolean
C0023895 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
Kidney Disease | Renal dysfunction
Item
manifest renal diseases with renal dysfunction
boolean
C0022658 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
Heart Disease
Item
relevant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Investigational Therapy Breast Carcinoma
Item
preceding therapy of breast tumour under investigation
boolean
C0949266 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Hooked wire Placement Attempt
Item
patients with multiple attempts of hook-wire placement in preparation of surgery
boolean
C0441180 (UMLS CUI [1,1])
C0589567 (UMLS CUI [1,2])
C1516084 (UMLS CUI [1,3])
Dementia Interferes with Comprehension Study Protocol | Mental condition Interferes with Comprehension Study Protocol | Dementia Interferes with Informed Consent | Mental condition Interferes with Informed Consent
Item
dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
boolean
C0497327 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
C0497327 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
Study Subject Participation Status
Item
simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment
boolean
C2348568 (UMLS CUI [1])

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