ID

38364

Description

Pre Operative Trastuzumab in Operable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01785420

Link

https://clinicaltrials.gov/show/NCT01785420

Keywords

Versions (1)
  1. 10/12/19 10/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma Breast Stage I NCT01785420

English

Eligibility Carcinoma Breast Stage I NCT01785420

1 forms  
Criteria
Description

Criteria

1. female subjects aged 18 years or older.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. histologically and/or cytologically confirmed diagnosis of breast cancer. clinical stages breast cancer: her2 positive, t1 or t2 or t3, n0 or n1, resectable t4, or resectable n2, (all m0)
Description

Breast Carcinoma | HER2-positive carcinoma of breast Resectable TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C1960398
UMLS CUI [2,2]
C1514888
UMLS CUI [2,3]
C0474926
3. documentation of erbb-2 gene amplification by fish (as defined by a ratio >2.2) or chromogenic in situ hybridization (cish, as defined by the manufacturer's kit instruction) or documentation of erbb-2-overexpression by ihc (defined as ihc3+, or ihc2+ with fish or cish confirmation) based on local laboratory.
Description

HER2 gene amplification FISH | HER2 gene amplification CISH | HER2 Overexpression Immunohistochemistry | HER2 Overexpression FISH | HER2 Overexpression CISH

Data type

boolean

Alias
UMLS CUI [1,1]
C1512127
UMLS CUI [1,2]
C0162789
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C1516514
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C1514559
UMLS CUI [3,3]
C0021044
UMLS CUI [4,1]
C0069515
UMLS CUI [4,2]
C1514559
UMLS CUI [4,3]
C0162789
UMLS CUI [5,1]
C0069515
UMLS CUI [5,2]
C1514559
UMLS CUI [5,3]
C1516514
4. lvef within institutional range of normal as measured by muga or echo.
Description

Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
5. screening laboratory values within the following parameters:
Description

Screening Laboratory Results

Data type

boolean

Alias
UMLS CUI [1,1]
C1710032
UMLS CUI [1,2]
C1254595
1. absolute neutrophil count (anc) ≥1.5 x 109 /l (1500/mm3)
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count ≥100 x 109/l (100,000/mm3)
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
3. hemoglobin ≥9.0 g/dl (90 g/l)
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
4. serum creatinine ≤1.5 x upper limit of normal (uln)
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
5. total bilirubin ≤1.5 x uln (<3 uln if gilbert's disease) 6aspartate aminotransferase (ast) and/or alanine aminotransferase (alt)
Description

Serum total bilirubin measurement | Gilbert Disease | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0017551
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
2.5 x uln
Description

ID.11

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. bilateral breast cancer
Description

Bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
2. active uncontrolled cardiac disease, including cardiomyopathy, chf (new york heart association [nyha] functional classification of ≥3), unstable angina, and myocardial infarction (within 12 months of study entry).
Description

Heart Disease Uncontrolled | Cardiomyopathy | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0878544
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0027051
3. inadequately controlled hypertension (ie, systolic blood pressure [bp] > 180 mm hg or diastolic bp > 100 mm hg).
Description

Poor hypertension control | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
4. family history of congenital long or short qt syndrome, brugada syndrome or qt/qtc interval > 0.45 second or known history of qt/qtc prolongation or torsade de pointe (tdp).
Description

Family history of long QT syndrome | Family history Short Qt Syndrome | Brugada Syndrome | QT interval duration | QTc | Prolonged QT interval | Prolongation of corrected QT interval | Torsades de Pointes

Data type

boolean

Alias
UMLS CUI [1]
C3839836
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C2348199
UMLS CUI [3]
C1142166
UMLS CUI [4]
C0577807
UMLS CUI [5]
C0860814
UMLS CUI [6]
C0151878
UMLS CUI [7]
C4478837
UMLS CUI [8]
C0040479
5. significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, crohn's disease, malabsorption, or grade ≥2 diarrhea of any etiology at baseline).
Description

Gastrointestinal Disease chronic | Diarrhea Symptom Major | Crohn Disease | Malabsorption | Diarrhea CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0011991
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C0205164
UMLS CUI [3]
C0010346
UMLS CUI [4]
C3714745
UMLS CUI [5,1]
C0011991
UMLS CUI [5,2]
C1516728
6. women who are pregnant, breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Carcinoma Breast Stage I NCT01785420

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Gender | Age
Item
1. female subjects aged 18 years or older.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma | HER2-positive carcinoma of breast Resectable TNM Breast tumor staging
Item
2. histologically and/or cytologically confirmed diagnosis of breast cancer. clinical stages breast cancer: her2 positive, t1 or t2 or t3, n0 or n1, resectable t4, or resectable n2, (all m0)
boolean
C0678222 (UMLS CUI [1])
C1960398 (UMLS CUI [2,1])
C1514888 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
HER2 gene amplification FISH | HER2 gene amplification CISH | HER2 Overexpression Immunohistochemistry | HER2 Overexpression FISH | HER2 Overexpression CISH
Item
3. documentation of erbb-2 gene amplification by fish (as defined by a ratio >2.2) or chromogenic in situ hybridization (cish, as defined by the manufacturer's kit instruction) or documentation of erbb-2-overexpression by ihc (defined as ihc3+, or ihc2+ with fish or cish confirmation) based on local laboratory.
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C1516514 (UMLS CUI [2,2])
C0069515 (UMLS CUI [3,1])
C1514559 (UMLS CUI [3,2])
C0021044 (UMLS CUI [3,3])
C0069515 (UMLS CUI [4,1])
C1514559 (UMLS CUI [4,2])
C0162789 (UMLS CUI [4,3])
C0069515 (UMLS CUI [5,1])
C1514559 (UMLS CUI [5,2])
C1516514 (UMLS CUI [5,3])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
4. lvef within institutional range of normal as measured by muga or echo.
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Screening Laboratory Results
Item
5. screening laboratory values within the following parameters:
boolean
C1710032 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Absolute neutrophil count
Item
1. absolute neutrophil count (anc) ≥1.5 x 109 /l (1500/mm3)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count ≥100 x 109/l (100,000/mm3)
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
3. hemoglobin ≥9.0 g/dl (90 g/l)
boolean
C0518015 (UMLS CUI [1])
Creatinine measurement, serum
Item
4. serum creatinine ≤1.5 x upper limit of normal (uln)
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Gilbert Disease | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
5. total bilirubin ≤1.5 x uln (<3 uln if gilbert's disease) 6aspartate aminotransferase (ast) and/or alanine aminotransferase (alt)
boolean
C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
ID.11
Item
2.5 x uln
boolean
Item Group
C0680251 (UMLS CUI)
Bilateral breast cancer
Item
1. bilateral breast cancer
boolean
C0281267 (UMLS CUI [1])
Heart Disease Uncontrolled | Cardiomyopathy | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction
Item
2. active uncontrolled cardiac disease, including cardiomyopathy, chf (new york heart association [nyha] functional classification of ≥3), unstable angina, and myocardial infarction (within 12 months of study entry).
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0878544 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Poor hypertension control | Systolic Pressure | Diastolic blood pressure
Item
3. inadequately controlled hypertension (ie, systolic blood pressure [bp] > 180 mm hg or diastolic bp > 100 mm hg).
boolean
C0421190 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Family history of long QT syndrome | Family history Short Qt Syndrome | Brugada Syndrome | QT interval duration | QTc | Prolonged QT interval | Prolongation of corrected QT interval | Torsades de Pointes
Item
4. family history of congenital long or short qt syndrome, brugada syndrome or qt/qtc interval > 0.45 second or known history of qt/qtc prolongation or torsade de pointe (tdp).
boolean
C3839836 (UMLS CUI [1])
C0241889 (UMLS CUI [2,1])
C2348199 (UMLS CUI [2,2])
C1142166 (UMLS CUI [3])
C0577807 (UMLS CUI [4])
C0860814 (UMLS CUI [5])
C0151878 (UMLS CUI [6])
C4478837 (UMLS CUI [7])
C0040479 (UMLS CUI [8])
Gastrointestinal Disease chronic | Diarrhea Symptom Major | Crohn Disease | Malabsorption | Diarrhea CTCAE Grades
Item
5. significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, crohn's disease, malabsorption, or grade ≥2 diarrhea of any etiology at baseline).
boolean
C0017178 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0011991 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0010346 (UMLS CUI [3])
C3714745 (UMLS CUI [4])
C0011991 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
6. women who are pregnant, breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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