ID

43595

Beschreibung

Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00397761

Link

https://clinicaltrials.gov/show/NCT00397761

Stichworte

Versionen (3)
  1. 14.01.17 14.01.17 -
  2. 14.01.17 14.01.17 -
  3. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00397761

Englisch

Eligibility Breast Cancer NCT00397761

1 Formulare  
Criteria
Beschreibung

Criteria

histologically confirmed infiltrating carcinoma of the breast or inflammatory breast cancer
Beschreibung

Invasive carcinoma of breast | Inflammatory Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0278601
stage ii-iiib disease (t1-4, n1-2, m0)
Beschreibung

Disease TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
previously untreated disease
Beschreibung

Disease untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332155
previously unresected disease
Beschreibung

Disease Unresected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2986425
high-risk disease that is not resectable by lumpectomy alone
Beschreibung

Disease High risk | Lumpectomy Alone Insufficient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332167
UMLS CUI [2,1]
C0740370
UMLS CUI [2,2]
C0205171
UMLS CUI [2,3]
C0231180
any her2/neu status (positive, negative, or unknown) allowed
Beschreibung

erbB-2 Receptor Status Positive | erbB-2 Receptor Status Negative | erbB-2 Receptor Status Unknown

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1514241
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C0449438
UMLS CUI [3,3]
C0439673
hormone receptor status:
Beschreibung

Hormone Receptor Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
any estrogen/progesterone status (positive, negative, or unknown) allowed
Beschreibung

Estrogen receptor positive status | Progesterone Receptor Status Positive | Estrogen receptor negative status | Progesterone Receptor Status Negative | estrogen receptor status unknown | progesterone receptor status unknown

Datentyp

boolean

Alias
UMLS CUI [1]
C1719706
UMLS CUI [2,1]
C1514471
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C1719707
UMLS CUI [4,1]
C1514471
UMLS CUI [4,2]
C1513916
UMLS CUI [5,1]
C0279758
UMLS CUI [5,2]
C0439673
UMLS CUI [6]
C0279768
patient characteristics:
Beschreibung

Client Characteristics

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
female
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
menopausal status not specified
Beschreibung

Menopausal Status Unspecified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
ecog performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
absolute neutrophil count > 1,500/mm³
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 100,000/mm³
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin > 9.0 g/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
creatinine < 1.5 mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin < 1.5 times upper limit of normal (uln)
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
alt and ast < 2.5 times uln (5 times uln if due to gilbert's disease)
Beschreibung

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Gilbert Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0017551
alkaline phosphatase < 2.5 times uln (5 times uln if due to gilbert's disease)
Beschreibung

Alkaline phosphatase measurement | Gilbert Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0017551
prior concurrent therapy:
Beschreibung

Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beschreibung

disease characteristic

Datentyp

boolean

Alias
UMLS CUI [1]
C0599878
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT00397761

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Invasive carcinoma of breast | Inflammatory Breast Carcinoma
Item
histologically confirmed infiltrating carcinoma of the breast or inflammatory breast cancer
boolean
C0853879 (UMLS CUI [1])
C0278601 (UMLS CUI [2])
Disease TNM clinical staging
Item
stage ii-iiib disease (t1-4, n1-2, m0)
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Disease untreated
Item
previously untreated disease
boolean
C0012634 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Disease Unresected
Item
previously unresected disease
boolean
C0012634 (UMLS CUI [1,1])
C2986425 (UMLS CUI [1,2])
Disease High risk | Lumpectomy Alone Insufficient
Item
high-risk disease that is not resectable by lumpectomy alone
boolean
C0012634 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0740370 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C0231180 (UMLS CUI [2,3])
erbB-2 Receptor Status Positive | erbB-2 Receptor Status Negative | erbB-2 Receptor Status Unknown
Item
any her2/neu status (positive, negative, or unknown) allowed
boolean
C0069515 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0069515 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0069515 (UMLS CUI [3,1])
C0449438 (UMLS CUI [3,2])
C0439673 (UMLS CUI [3,3])
Hormone Receptor Status
Item
hormone receptor status:
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Estrogen receptor positive status | Progesterone Receptor Status Positive | Estrogen receptor negative status | Progesterone Receptor Status Negative | estrogen receptor status unknown | progesterone receptor status unknown
Item
any estrogen/progesterone status (positive, negative, or unknown) allowed
boolean
C1719706 (UMLS CUI [1])
C1514471 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1719707 (UMLS CUI [3])
C1514471 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
C0279758 (UMLS CUI [5,1])
C0439673 (UMLS CUI [5,2])
C0279768 (UMLS CUI [6])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C3829127 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count > 1,500/mm³
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100,000/mm³
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin > 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine < 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 1.5 times upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Gilbert Disease
Item
alt and ast < 2.5 times uln (5 times uln if due to gilbert's disease)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0017551 (UMLS CUI [3])
Alkaline phosphatase measurement | Gilbert Disease
Item
alkaline phosphatase < 2.5 times uln (5 times uln if due to gilbert's disease)
boolean
C0201850 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
disease characteristic
Item
see disease characteristics
boolean
C0599878 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

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