ID

26312

Beschrijving

Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00738777

Link

https://clinicaltrials.gov/show/NCT00738777

Trefwoorden

Versies (1)
  1. 16-10-17 16-10-17 -
Houder van rechten

See clinicaltrials.gov

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16 oktober 2017

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00738777

Engels

Eligibility Breast Cancer NCT00738777

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with proven invasive adenocarcinoma of the breast
Beschrijving

Breast adenocarcinoma Invasive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
any tumor with a size ≥ 1cm (not inflammatory breast cancer)
Beschrijving

Neoplasm Size | Exception Inflammatory Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0278601
who-performance score 0 or 1
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
clues of metastatic disease by clinical examination according to most recent nabon guidelines
Beschrijving

Evidence of Neoplasm Metastasis Clinical examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C1456356
multicentric breast cancer
Beschrijving

Multicentric Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2986664
inflammatory breast cancer
Beschrijving

Inflammatory Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0278601
hormone replacement during the last 12 months
Beschrijving

Hormone replacement therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0282402
other systemic treatment during the waiting time till surgery
Beschrijving

systemic therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1515119
already planned date for surgery within the next 2 weeks
Beschrijving

Date Operative Surgical Procedure Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C1301732
any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol
Beschrijving

Condition Informed Consent Limited | Condition Protocol Compliance Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
patient's refusal to undergo a core biopsy procedure of the primary tumor before the start of treatment
Beschrijving

Core biopsy Primary tumor Procedure refused

Datatype

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C0677930
UMLS CUI [1,3]
C0420590
nb: a concomitant malignancy within the last five years is not an exclusion criterium, because survival is not the primary endpoint. just as prior invasive breast cancer or dcis within the last 15 years is not an exclusion criterium.
Beschrijving

Cancer Other allowed | Invasive carcinoma of breast Previous allowed | DCIS Previous allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0007124
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C0683607
nb: patients of childbearing potential must implement adequate non-hormonal contraceptive measures during the study.
Beschrijving

Childbearing Potential Contraceptive methods | Hormonal contraception Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C2985296
UMLS CUI [2,2]
C2828389
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Similar models

Eligibility Breast Cancer NCT00738777

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma Invasive
Item
patients with proven invasive adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
Neoplasm Size | Exception Inflammatory Breast Carcinoma
Item
any tumor with a size ≥ 1cm (not inflammatory breast cancer)
boolean
C0027651 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0278601 (UMLS CUI [2,2])
WHO performance status scale
Item
who-performance score 0 or 1
boolean
C1298650 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Evidence of Neoplasm Metastasis Clinical examination
Item
clues of metastatic disease by clinical examination according to most recent nabon guidelines
boolean
C0332120 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
Multicentric Breast Carcinoma
Item
multicentric breast cancer
boolean
C2986664 (UMLS CUI [1])
Inflammatory Breast Carcinoma
Item
inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
Hormone replacement therapy
Item
hormone replacement during the last 12 months
boolean
C0282402 (UMLS CUI [1])
systemic therapy
Item
other systemic treatment during the waiting time till surgery
boolean
C1515119 (UMLS CUI [1])
Date Operative Surgical Procedure Planned
Item
already planned date for surgery within the next 2 weeks
boolean
C0011008 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Condition Informed Consent Limited | Condition Protocol Compliance Limited
Item
any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol
boolean
C0348080 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Core biopsy Primary tumor Procedure refused
Item
patient's refusal to undergo a core biopsy procedure of the primary tumor before the start of treatment
boolean
C1318309 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0420590 (UMLS CUI [1,3])
Cancer Other allowed | Invasive carcinoma of breast Previous allowed | DCIS Previous allowed
Item
nb: a concomitant malignancy within the last five years is not an exclusion criterium, because survival is not the primary endpoint. just as prior invasive breast cancer or dcis within the last 15 years is not an exclusion criterium.
boolean
C1707251 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0007124 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Childbearing Potential Contraceptive methods | Hormonal contraception Excluded
Item
nb: patients of childbearing potential must implement adequate non-hormonal contraceptive measures during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
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