ID

38179

Beschrijving

Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT02017496

Link

https://clinicaltrials.gov/show/NCT02017496

Trefwoorden

  1. 24-09-19 24-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 september 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT02017496

Eligibility Breast Cancer NCT02017496

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with locally advanced breast cancer (ct3-4c, n0-3) with tumors > 5 cm, as determined by mri, where the present guidelines include them for neoadjuvant systemic therapy
Beschrijving

Locally advanced breast cancer TNM Breast tumor staging | Tumor size MRI | Guideline recommendation Neoadjuvant Therapy Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C0681471
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C0205373
written informed consent (informed consent document to be approved by the independent ethics committee) prior to study-related procedures and examinations.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
female age > 18 years
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
able to comply with the protocol
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
histologically confirmed adenocarcinoma of the breast
Beschrijving

Breast adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0858252
american society of anesthesiologist's physical status category 1 or 2 before surgery. category 1 and 2 includes healthy patients and patients with only mild systemic disease, whereas category 3 includes patients with more serious systemic diseases (but still operable).
Beschrijving

ASA physical status classification

Datatype

boolean

Alias
UMLS CUI [1]
C0450990
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
inflammatory breast cancer or diffuse locoregional involvement of the skin
Beschrijving

Inflammatory Breast Carcinoma | Skin Involvement Locoregional Diffuse

Datatype

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2,1]
C1123023
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C1947913
UMLS CUI [2,4]
C0205219
stage iv - metastatic disease
Beschrijving

Neoplasm Metastasis TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0474926
locoregional relapse of earlier breast cancer
Beschrijving

Breast Carcinoma Previous | Relapse Locoregional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C1947913
inability (irrespective of reason) to receive the recommended neoadjuvant treatment,- as decided by the treating physician.
Beschrijving

Neoadjuvant Therapy Receive Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
american society of anesthesiologist's physical status category 4-5
Beschrijving

ASA physical status classification

Datatype

boolean

Alias
UMLS CUI [1]
C0450990

Similar models

Eligibility Breast Cancer NCT02017496

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer TNM Breast tumor staging | Tumor size MRI | Guideline recommendation Neoadjuvant Therapy Systemic
Item
patients with locally advanced breast cancer (ct3-4c, n0-3) with tumors > 5 cm, as determined by mri, where the present guidelines include them for neoadjuvant systemic therapy
boolean
C3495949 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0681471 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
Informed Consent
Item
written informed consent (informed consent document to be approved by the independent ethics committee) prior to study-related procedures and examinations.
boolean
C0021430 (UMLS CUI [1])
Gender | Age
Item
female age > 18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Protocol Compliance
Item
able to comply with the protocol
boolean
C0525058 (UMLS CUI [1])
Breast adenocarcinoma
Item
histologically confirmed adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1])
ASA physical status classification
Item
american society of anesthesiologist's physical status category 1 or 2 before surgery. category 1 and 2 includes healthy patients and patients with only mild systemic disease, whereas category 3 includes patients with more serious systemic diseases (but still operable).
boolean
C0450990 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Inflammatory Breast Carcinoma | Skin Involvement Locoregional Diffuse
Item
inflammatory breast cancer or diffuse locoregional involvement of the skin
boolean
C0278601 (UMLS CUI [1])
C1123023 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C1947913 (UMLS CUI [2,3])
C0205219 (UMLS CUI [2,4])
Neoplasm Metastasis TNM Breast tumor staging
Item
stage iv - metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Breast Carcinoma Previous | Relapse Locoregional
Item
locoregional relapse of earlier breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0035020 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
Neoadjuvant Therapy Receive Unable
Item
inability (irrespective of reason) to receive the recommended neoadjuvant treatment,- as decided by the treating physician.
boolean
C0600558 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
ASA physical status classification
Item
american society of anesthesiologist's physical status category 4-5
boolean
C0450990 (UMLS CUI [1])

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