ID

34960

Description

Study of Optimizing Neoadjuvant Regimens in Subtypes of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02041338

Link

https://clinicaltrials.gov/show/NCT02041338

Keywords

Versions (1)
  1. 2/5/19 2/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02041338

English

Eligibility Breast Cancer NCT02041338

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage iia-iiic breast cancer patients plan to receive neoadjuvant chemotherapy
Description

Breast Carcinoma TNM Breast tumor staging | Chemotherapy Neoadjuvant Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C1301732
patients have enough tissue sample to do ihc test for subtype classification
Description

Tissue specimen Available Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0021044
patients have at least one measurable lesion according to recist1.1
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
kps≥80
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
no prior treatment for breast cancer
Description

Prior Therapy Absent Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
adequate bone marrow (neutrophil count ≥1500 ml and platelet count ≥100,000 ml), renal (serum creatinine <1.5 times the upper limit of normal [uln] or a creatinine clearance of ≥60 ml/minute), hepatic (total bilirubin ≤1.5 uln; alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase ≤2.5 uln), and cardiac function (assessed by electrocardiogram or thoracic radiography) were required.
Description

Bone Marrow function | Neutrophil count | Platelet Count measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Cardiac function ECG | Cardiac function Thoracic Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0373595
UMLS CUI [7]
C0232741
UMLS CUI [8]
C1278039
UMLS CUI [9]
C0201836
UMLS CUI [10]
C0201899
UMLS CUI [11]
C0201850
UMLS CUI [12,1]
C0232164
UMLS CUI [12,2]
C0013798
UMLS CUI [13,1]
C0232164
UMLS CUI [13,2]
C3665494
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
fertile women were excluded if pregnant or lactating or if they were not using adequate contraception.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
previous chemotherapy for breast cancer.
Description

Prior Chemotherapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
history of other serious illness (e.g. congestive heart failure, angina pectoris, uncontrolled hypertension or arrhythmia, clinically significant neurologic or psychiatric disorders, uncontrolled serious infection, aids), had an organ allograft, severe gastrointestinal disorder, or other neoplasias (except for in situ cervical cancer, non-melanoma skin cancer, or previous diagnosis of cancer with no evidence of disease for >10 years).
Description

Illness Serious | Congestive heart failure | Angina Pectoris | Uncontrolled hypertension | Cardiac Arrhythmia Uncontrolled | Nervous system disorder | Mental disorders | Communicable Disease Serious Uncontrolled | AIDS | Organ Allograft | Gastrointestinal Disease Severe | Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma | Exception Malignant Neoplasm Disease Free

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0002962
UMLS CUI [4]
C1868885
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0027765
UMLS CUI [7]
C0004936
UMLS CUI [8,1]
C0009450
UMLS CUI [8,2]
C0205404
UMLS CUI [8,3]
C0205318
UMLS CUI [9]
C0001175
UMLS CUI [10,1]
C0178784
UMLS CUI [10,2]
C0040739
UMLS CUI [11,1]
C0017178
UMLS CUI [11,2]
C0205082
UMLS CUI [12]
C1707251
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0851140
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0699893
UMLS CUI [15,1]
C1705847
UMLS CUI [15,2]
C0006826
UMLS CUI [15,3]
C0012634
UMLS CUI [15,4]
C0332296
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Similar models

Eligibility Breast Cancer NCT02041338

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging | Chemotherapy Neoadjuvant Planned
Item
stage iia-iiic breast cancer patients plan to receive neoadjuvant chemotherapy
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Tissue specimen Available Immunohistochemistry
Item
patients have enough tissue sample to do ihc test for subtype classification
boolean
C1292533 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
Measurable lesion Quantity
Item
patients have at least one measurable lesion according to recist1.1
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
kps≥80
boolean
C0206065 (UMLS CUI [1])
Prior Therapy Absent Breast Carcinoma
Item
no prior treatment for breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Bone Marrow function | Neutrophil count | Platelet Count measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Cardiac function ECG | Cardiac function Thoracic Radiography
Item
adequate bone marrow (neutrophil count ≥1500 ml and platelet count ≥100,000 ml), renal (serum creatinine <1.5 times the upper limit of normal [uln] or a creatinine clearance of ≥60 ml/minute), hepatic (total bilirubin ≤1.5 uln; alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase ≤2.5 uln), and cardiac function (assessed by electrocardiogram or thoracic radiography) were required.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0373595 (UMLS CUI [6])
C0232741 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0201850 (UMLS CUI [11])
C0232164 (UMLS CUI [12,1])
C0013798 (UMLS CUI [12,2])
C0232164 (UMLS CUI [13,1])
C3665494 (UMLS CUI [13,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
fertile women were excluded if pregnant or lactating or if they were not using adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Prior Chemotherapy Breast Carcinoma
Item
previous chemotherapy for breast cancer.
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Illness Serious | Congestive heart failure | Angina Pectoris | Uncontrolled hypertension | Cardiac Arrhythmia Uncontrolled | Nervous system disorder | Mental disorders | Communicable Disease Serious Uncontrolled | AIDS | Organ Allograft | Gastrointestinal Disease Severe | Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma | Exception Malignant Neoplasm Disease Free
Item
history of other serious illness (e.g. congestive heart failure, angina pectoris, uncontrolled hypertension or arrhythmia, clinically significant neurologic or psychiatric disorders, uncontrolled serious infection, aids), had an organ allograft, severe gastrointestinal disorder, or other neoplasias (except for in situ cervical cancer, non-melanoma skin cancer, or previous diagnosis of cancer with no evidence of disease for >10 years).
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0027765 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
C0009450 (UMLS CUI [8,1])
C0205404 (UMLS CUI [8,2])
C0205318 (UMLS CUI [8,3])
C0001175 (UMLS CUI [9])
C0178784 (UMLS CUI [10,1])
C0040739 (UMLS CUI [10,2])
C0017178 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C1707251 (UMLS CUI [12])
C1705847 (UMLS CUI [13,1])
C0851140 (UMLS CUI [13,2])
C1705847 (UMLS CUI [14,1])
C0699893 (UMLS CUI [14,2])
C1705847 (UMLS CUI [15,1])
C0006826 (UMLS CUI [15,2])
C0012634 (UMLS CUI [15,3])
C0332296 (UMLS CUI [15,4])
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