ID

38179

Description

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

Keywords

Versions (1)
  1. 9/24/19 9/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 24, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Cancer NCT02017496

English

Eligibility Breast Cancer NCT02017496

1 forms  
Inclusion Criteria
Description

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
Description

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

Data type

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.
Description

Informed Consent

Data type

boolean

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

Gender | Age

Data type

boolean

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

Protocol Compliance

Data type

boolean

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

Breast adenocarcinoma

Data type

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).
Description

ASA physical status classification

Data type

boolean

Alias
UMLS CUI [1]
C0450990
Exclusion Criteria
Description

Exclusion Criteria

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

Inflammatory Breast Carcinoma | Skin Involvement Locoregional Diffuse

Data type

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
Description

Neoplasm Metastasis TNM Breast tumor staging

Data type

boolean

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

Breast Carcinoma Previous | Relapse Locoregional

Data type

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.
Description

Neoadjuvant Therapy Receive Unable

Data type

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
Description

ASA physical status classification

Data type

boolean

Alias
UMLS CUI [1]
C0450990
Back to the top of the page

Similar models

Eligibility Breast Cancer NCT02017496

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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