ID

17738

Description

Capecitabine in Women With Operable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00148720

Link

https://clinicaltrials.gov/show/NCT00148720

Keywords

Versions (1)
  1. 9/30/16 9/30/16 -
Uploaded on

September 30, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Invasive Breast Carcinoma NCT00148720

English

Eligibility Invasive Breast Carcinoma NCT00148720

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological confirmation of primary invasive breast cancer
Description

Primary invasive malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C4076461
stage i-iii operable breast cancer.
Description

Breast Carcinoma Operable | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205188
UMLS CUI [2]
C3258246
primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation
Description

primary tumor size | Radiographic imaging | Palpation

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0456389
UMLS CUI [2]
C0457276
UMLS CUI [3]
C0030247
women greater than 18 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
ecog performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
wbc > 4000/mm3
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
platelet count > 100,000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
sgot < 2x uln
Description

Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
calculated creatinine clearance > 50ml/min
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of metastatic (stage iv) cancer on physical exam or any diagnostic study.
Description

Neoplasm Metastasis Evidence of | Carcinoma breast stage IV | Physical Examination | Diagnostic tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0278488
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0086143
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
inflammatory breast cancer
Description

Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278601
her2 positive disease
Description

HER2-positive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C1960398
history of hypersensitivity to a 5-fu or known dihydropyrimidine dehydrogenase (dpd) deficiency
Description

Hypersensitivity Fluorouracil | Dihydropyrimidine Dehydrogenase Deficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016360
UMLS CUI [2]
C1959620
uncontrolled intercurrent illness
Description

Intercurrent disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0277557
UMLS CUI [1,2]
C0205318
prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant.
Description

Breast Carcinoma Previous | irradiation of breast Previous | Prior Chemotherapy | Prior Chemotherapy High dose | Stem cell transplant | Bone Marrow Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C2148528
UMLS CUI [2,2]
C0205156
UMLS CUI [3]
C1514457
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C0444956
UMLS CUI [5]
C1504389
UMLS CUI [6]
C0005961
excisional biopsy performed prior to enrollment
Description

Excision biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0184921
uncontrolled coagulopathy
Description

Blood Coagulation Disorder Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205318
lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
Description

upper gastrointestinal tract Integrity Physical Lacking | Malabsorption Syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C1268997
UMLS CUI [1,2]
C1947912
UMLS CUI [1,3]
C0205485
UMLS CUI [1,4]
C0332268
UMLS CUI [2]
C0024523
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Similar models

Eligibility Invasive Breast Carcinoma NCT00148720

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Primary invasive malignant neoplasm of female breast
Item
histological confirmation of primary invasive breast cancer
boolean
C4076461 (UMLS CUI [1])
Breast Carcinoma Operable | TNM clinical staging
Item
stage i-iii operable breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
primary tumor size | Radiographic imaging | Palpation
Item
primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation
boolean
C0677930 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0457276 (UMLS CUI [2])
C0030247 (UMLS CUI [3])
Gender | Age
Item
women greater than 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc > 4000/mm3
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
sgot < 2x uln
boolean
C0201899 (UMLS CUI [1])
Creatinine clearance measurement
Item
calculated creatinine clearance > 50ml/min
boolean
C0373595 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Evidence of | Carcinoma breast stage IV | Physical Examination | Diagnostic tests
Item
evidence of metastatic (stage iv) cancer on physical exam or any diagnostic study.
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0278488 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0086143 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Inflammatory Breast Carcinoma
Item
inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
HER2-positive carcinoma of breast
Item
her2 positive disease
boolean
C1960398 (UMLS CUI [1])
Hypersensitivity Fluorouracil | Dihydropyrimidine Dehydrogenase Deficiency
Item
history of hypersensitivity to a 5-fu or known dihydropyrimidine dehydrogenase (dpd) deficiency
boolean
C0020517 (UMLS CUI [1,1])
C0016360 (UMLS CUI [1,2])
C1959620 (UMLS CUI [2])
Intercurrent disease Uncontrolled
Item
uncontrolled intercurrent illness
boolean
C0277557 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Breast Carcinoma Previous | irradiation of breast Previous | Prior Chemotherapy | Prior Chemotherapy High dose | Stem cell transplant | Bone Marrow Transplantation
Item
prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant.
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2148528 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3])
C1514457 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
C1504389 (UMLS CUI [5])
C0005961 (UMLS CUI [6])
Excision biopsy
Item
excisional biopsy performed prior to enrollment
boolean
C0184921 (UMLS CUI [1])
Blood Coagulation Disorder Uncontrolled
Item
uncontrolled coagulopathy
boolean
C0005779 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
upper gastrointestinal tract Integrity Physical Lacking | Malabsorption Syndrome
Item
lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
boolean
C1268997 (UMLS CUI [1,1])
C1947912 (UMLS CUI [1,2])
C0205485 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
C0024523 (UMLS CUI [2])
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