ID

21234

Beschrijving

Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00870168

Link

https://clinicaltrials.gov/show/NCT00870168

Trefwoorden

  1. 14-04-17 14-04-17 -
Geüploaded op

14 april 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00870168

Eligibility Breast Cancer NCT00870168

Criteria
Beschrijving

Criteria

histologically confirmed adenocarcinoma of the breast
Beschrijving

adenocarcinoma of the breast, histologically confirmed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0019638
metastatic disease
Beschrijving

metastatic adenocarcinoma of the breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0027627
no inflammatory breast cancer
Beschrijving

inflammatory breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0278601
measurable disease according to recist criteria
Beschrijving

adenocarcinoma of the breast, measurable disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C1513041
hormone receptor status:
Beschrijving

adenocarcinoma of the breast, hormone receptor status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0019929
UMLS CUI [1,3]
C0449438
estrogen receptor- and/or progesterone receptor-negative by ihc
Beschrijving

adenocarcinoma of the breast, estrogen and progesterone receptor immunhis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0034804
UMLS CUI [1,3]
C0034833
UMLS CUI [1,4]
C0021044
patient characteristics:
Beschrijving

patient characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
menopausal status not specified
Beschrijving

menopausal status

Datatype

boolean

Alias
UMLS CUI [1]
C0455962
who performance status 0-2
Beschrijving

who performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
life expectancy > 3 months
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
anc > 1.5 x 10^9/l
Beschrijving

absolute neutrophile count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 100 x 10^9/l
Beschrijving

platelet count

Datatype

boolean

Alias
UMLS CUI [1]
C0005821
liver transaminases ≤ 3 times upper limit of normal (uln)
Beschrijving

liver transaminases

Datatype

boolean

Alias
UMLS CUI [1]
C0002594
alkaline phosphatase ≤ 3 times uln
Beschrijving

alkaline phosphatase

Datatype

boolean

Alias
UMLS CUI [1]
C0201850
bilirubin ≤ 1.5 times uln
Beschrijving

bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
creatinine ≤ 2 times uln
Beschrijving

creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
not pregnant or nursing
Beschrijving

pregnancy, breast feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
fertile patients must use effective contraception
Beschrijving

fertile patients with effective contraception

Datatype

boolean

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0700589
no allergy to xylocaine
Beschrijving

xylocaine allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0699094
UMLS CUI [1,2]
C0020517
no heart failure, or kidney, bone marrow, respiratory, or liver insufficiency
Beschrijving

heart failure, kidney insuffiency, bone marrow insufficiency, respiratory insufficiency, liver insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1565489
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0231179
UMLS CUI [4]
C0035229
UMLS CUI [5]
C1306571
prior concurrent therapy:
Beschrijving

concurrent therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0009429
no prior first-line treatment for metastatic disease
Beschrijving

first-line treatment for metastatic disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1708063

Similar models

Eligibility Breast Cancer NCT00870168

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
adenocarcinoma of the breast, histologically confirmed
Item
histologically confirmed adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
metastatic adenocarcinoma of the breast
Item
metastatic disease
boolean
C0858252 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
inflammatory breast cancer
Item
no inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
adenocarcinoma of the breast, measurable disease
Item
measurable disease according to recist criteria
boolean
C0858252 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
adenocarcinoma of the breast, hormone receptor status
Item
hormone receptor status:
boolean
C0858252 (UMLS CUI [1,1])
C0019929 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
adenocarcinoma of the breast, estrogen and progesterone receptor immunhis
Item
estrogen receptor- and/or progesterone receptor-negative by ihc
boolean
C0858252 (UMLS CUI [1,1])
C0034804 (UMLS CUI [1,2])
C0034833 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
patient characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
menopausal status
Item
menopausal status not specified
boolean
C0455962 (UMLS CUI [1])
who performance status
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
life expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
absolute neutrophile count
Item
anc > 1.5 x 10^9/l
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count > 100 x 10^9/l
boolean
C0005821 (UMLS CUI [1])
liver transaminases
Item
liver transaminases ≤ 3 times upper limit of normal (uln)
boolean
C0002594 (UMLS CUI [1])
alkaline phosphatase
Item
alkaline phosphatase ≤ 3 times uln
boolean
C0201850 (UMLS CUI [1])
bilirubin
Item
bilirubin ≤ 1.5 times uln
boolean
C1278039 (UMLS CUI [1])
creatinine
Item
creatinine ≤ 2 times uln
boolean
C0201976 (UMLS CUI [1])
pregnancy, breast feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
fertile patients with effective contraception
Item
fertile patients must use effective contraception
boolean
C1960468 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
xylocaine allergy
Item
no allergy to xylocaine
boolean
C0699094 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
heart failure, kidney insuffiency, bone marrow insufficiency, respiratory insufficiency, liver insufficiency
Item
no heart failure, or kidney, bone marrow, respiratory, or liver insufficiency
boolean
C0018801 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0231179 (UMLS CUI [3,2])
C0035229 (UMLS CUI [4])
C1306571 (UMLS CUI [5])
concurrent therapy
Item
prior concurrent therapy:
boolean
C0009429 (UMLS CUI [1])
first-line treatment for metastatic disease
Item
no prior first-line treatment for metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])

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