ID

35096

Descripción

A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis by Detecting CTCs; ODM derived from: https://clinicaltrials.gov/show/NCT02510781

Link

https://clinicaltrials.gov/show/NCT02510781

Palabras clave

Versiones (1)
  1. 16/2/19 16/2/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de febrero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02510781

Inglés

Eligibility Breast Neoplasms NCT02510781

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
18≤aged＜70
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
pathologic diagnosis of invasive breast cancer，staging ii to iii，the diameters≥2cm indicated by mri or axillary lymph node（+）
Descripción

Invasive carcinoma of breast TNM Breast tumor staging | Diameter MRI | Positive Axillary Lymph Node

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C1301886
UMLS CUI [2,2]
C0024485
UMLS CUI [3]
C0677929
immunohistochemical（ihc） positive for 3+ or fish（+）
Descripción

Immunohistochemistry Positive | Fluorescent in situ hybridisation positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C3495875
clear hormone receptor（hr） status
Descripción

Hormone Receptor Status Clear

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C2963144
eastern cooperative oncology group(ecog)=0/1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
lvef≥55%
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
pathologic grading of miller and payne
Descripción

Miller and Payne Classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1883687
screening laboratory values with the following parameters：absolute neutrophils acount：≥1500/mm3,total bilirubin:≤2.0×ulm,aspartate transaminase (ast)/alt≤2.5×ulm,platelet≥80000/mm3，serum creatinine≤1.5×ulm
Descripción

Laboratory Results | Absolute neutrophil count | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Platelet Count measurement | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0948762
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0201976
no pregnant or nursing
Descripción

Pregnancy Absent | Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
signed informed consent forms
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure to any treatments for breast cancer
Descripción

Prior Therapy Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0678222
inflammatory/bilateral/iv stage breast cancer
Descripción

Inflammatory Breast Carcinoma | Bilateral breast cancer | Secondary malignant neoplasm of female breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2]
C0281267
UMLS CUI [3]
C0346993
poor physical condition
Descripción

Poor physical condition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2111874
pregnant or nursing
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
cardiac risk（congestive heart failure、arrhythmia、myocardial infarct、refractory hypertension（systolic pressure＞180mmhg/diastolic pressure＞100mmhg））
Descripción

Cardiac risk factors | Congestive heart failure | Cardiac Arrhythmia | Myocardial Infarction | Refractory hypertension | Systolic Pressure | Diastolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2024776
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0003811
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0860493
UMLS CUI [6]
C0871470
UMLS CUI [7]
C0428883
any other cancer within 5 years prior to screening with the exception of cervical carcinoma and non melanoma skin cancer
Descripción

Cancer Other | Exception Cervix carcinoma | Exception Skin carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0302592
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
allergic to chemotherapy drugs
Descripción

Hypersensitivity Antineoplastic Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003392
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Similar models

Eligibility Breast Neoplasms NCT02510781

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18≤aged＜70
boolean
C0001779 (UMLS CUI [1])
Invasive carcinoma of breast TNM Breast tumor staging | Diameter MRI | Positive Axillary Lymph Node
Item
pathologic diagnosis of invasive breast cancer，staging ii to iii，the diameters≥2cm indicated by mri or axillary lymph node（+）
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0677929 (UMLS CUI [3])
Immunohistochemistry Positive | Fluorescent in situ hybridisation positive
Item
immunohistochemical（ihc） positive for 3+ or fish（+）
boolean
C0021044 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C3495875 (UMLS CUI [2])
Hormone Receptor Status Clear
Item
clear hormone receptor（hr） status
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C2963144 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group(ecog)=0/1
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lvef≥55%
boolean
C0428772 (UMLS CUI [1])
Miller and Payne Classification
Item
pathologic grading of miller and payne
boolean
C1883687 (UMLS CUI [1])
Laboratory Results | Absolute neutrophil count | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Platelet Count measurement | Creatinine measurement, serum
Item
screening laboratory values with the following parameters：absolute neutrophils acount：≥1500/mm3,total bilirubin:≤2.0×ulm,aspartate transaminase (ast)/alt≤2.5×ulm,platelet≥80000/mm3，serum creatinine≤1.5×ulm
boolean
C1254595 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Pregnancy Absent | Breast Feeding Absent
Item
no pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent
Item
signed informed consent forms
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Breast Carcinoma
Item
prior exposure to any treatments for breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Inflammatory Breast Carcinoma | Bilateral breast cancer | Secondary malignant neoplasm of female breast
Item
inflammatory/bilateral/iv stage breast cancer
boolean
C0278601 (UMLS CUI [1])
C0281267 (UMLS CUI [2])
C0346993 (UMLS CUI [3])
Poor physical condition
Item
poor physical condition
boolean
C2111874 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiac risk factors | Congestive heart failure | Cardiac Arrhythmia | Myocardial Infarction | Refractory hypertension | Systolic Pressure | Diastolic blood pressure
Item
cardiac risk（congestive heart failure、arrhythmia、myocardial infarct、refractory hypertension（systolic pressure＞180mmhg/diastolic pressure＞100mmhg））
boolean
C2024776 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0860493 (UMLS CUI [5])
C0871470 (UMLS CUI [6])
C0428883 (UMLS CUI [7])
Cancer Other | Exception Cervix carcinoma | Exception Skin carcinoma
Item
any other cancer within 5 years prior to screening with the exception of cervical carcinoma and non melanoma skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0302592 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Hypersensitivity Antineoplastic Agents
Item
allergic to chemotherapy drugs
boolean
C0020517 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
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