ID

35856

Beschrijving

Recombinant Human Endostatin (EndostarTM) Injection in Treatment of Recurrent Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02489409

Link

https://clinicaltrials.gov/show/NCT02489409

Trefwoorden

Versies (1)
  1. 28-03-19 28-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Endostatins NCT02489409

Engels

Eligibility Endostatins NCT02489409

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 18～70 years old;
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status (ps) score: 0～1 score;
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
all patients were diagnosed as recurrent metastatic breast cancer retreatment by histopathology and computed tomography (ct) examination;
Beschrijving

Retreatment BREAST CANCER METASTATIC RECURRENT CT scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0376495
UMLS CUI [1,2]
C0741681
UMLS CUI [1,3]
C0040405
the measurable nidus≥1: patients whose nidus diameter ≥ 20 mm by normal ct or magnetic resonance image (mri) scanning, and ≥ 10 mm by spiral ct scanning;
Beschrijving

Nidus Measurable | Nidus Diameter CT scan | Nidus Diameter MRI scan | Nidus Diameter Spiral CT scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C1628997
UMLS CUI [1,2]
C1513040
UMLS CUI [2,1]
C1628997
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C1628997
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0024485
UMLS CUI [4,1]
C1628997
UMLS CUI [4,2]
C1301886
UMLS CUI [4,3]
C0860888
patients whose blood routine, hepatorenal function, electrolyte and cardiac function were basically normal without dysfunction of primary organs. white blood cell count (wbc) ≥4.0×109/l, neutrophile granulocyte count ≥1.5×109/l, platelet (plt) count
Beschrijving

Hematologic function | Liver function | Renal function | Electrolytes normal | Cardiac function | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0438240
UMLS CUI [5]
C0232164
UMLS CUI [6]
C0023508
UMLS CUI [7]
C0200633
UMLS CUI [8]
C0032181
≥100×109/l, hemoglobin (hgb) ≥95 g/l, serum bilirubin (bil) ≤1.5-fold upper limit of normal value, alanine transaminase (alt) and aspartate aminotransferase (ast) ≤2-fold upper limit of normal value, and serum creatinine (scr) ≤1.5mg/dl;
Beschrijving

Hemoglobin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201976
the expected survival time ＞3 months;
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
patients who could understand this study status and had signed the informed consent forms.
Beschrijving

Comprehension Study Protocol | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who had history of allergic responses to biological agents;
Beschrijving

Allergic Reaction Biological Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0005515
patients who were receiving other anti-tumor therapies;
Beschrijving

Cancer treatment Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
patients without measureable nidus;
Beschrijving

Nidus Measurable Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C1628997
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C0332268
others, including one of the following conditions: patients with uncontrolled central nervous system (cns) metastatic nidi, with dysfunction of important organs and severe cardiac diseases (congestive heart failure, uncontrollable arrhythmia, and angina pectoris, valvular heart disease, myocardial infarction and refractory hypertension that required long-term drug administration), with chronic infectious wound and with history of uncontrollable psychosis, and women in pregnant or lactation period.
Beschrijving

CNS metastases Uncontrolled | Organ dysfunction | Heart Diseases Severe | Congestive heart failure | Cardiac Arrhythmia Uncontrolled | Angina Pectoris | Heart valve disease | Myocardial Infarction | Refractory hypertension Requirement Administration of medication Long-term | Wounds Infectious chronic | Psychotic Disorders Uncontrolled | Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0349410
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0018802
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0002962
UMLS CUI [7]
C0018824
UMLS CUI [8]
C0027051
UMLS CUI [9,1]
C0860493
UMLS CUI [9,2]
C1514873
UMLS CUI [9,3]
C3469597
UMLS CUI [9,4]
C0443252
UMLS CUI [10,1]
C0043250
UMLS CUI [10,2]
C0009450
UMLS CUI [10,3]
C0205191
UMLS CUI [11,1]
C0033975
UMLS CUI [11,2]
C0205318
UMLS CUI [12]
C0032961
UMLS CUI [13]
C0006147
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Similar models

Eligibility Endostatins NCT02489409

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 18～70 years old;
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status (ps) score: 0～1 score;
boolean
C1520224 (UMLS CUI [1])
Retreatment BREAST CANCER METASTATIC RECURRENT CT scan
Item
all patients were diagnosed as recurrent metastatic breast cancer retreatment by histopathology and computed tomography (ct) examination;
boolean
C0376495 (UMLS CUI [1,1])
C0741681 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
Nidus Measurable | Nidus Diameter CT scan | Nidus Diameter MRI scan | Nidus Diameter Spiral CT scan
Item
the measurable nidus≥1: patients whose nidus diameter ≥ 20 mm by normal ct or magnetic resonance image (mri) scanning, and ≥ 10 mm by spiral ct scanning;
boolean
C1628997 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1628997 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C1628997 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C1628997 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0860888 (UMLS CUI [4,3])
Hematologic function | Liver function | Renal function | Electrolytes normal | Cardiac function | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement
Item
patients whose blood routine, hepatorenal function, electrolyte and cardiac function were basically normal without dysfunction of primary organs. white blood cell count (wbc) ≥4.0×109/l, neutrophile granulocyte count ≥1.5×109/l, platelet (plt) count
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0438240 (UMLS CUI [4])
C0232164 (UMLS CUI [5])
C0023508 (UMLS CUI [6])
C0200633 (UMLS CUI [7])
C0032181 (UMLS CUI [8])
Hemoglobin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
≥100×109/l, hemoglobin (hgb) ≥95 g/l, serum bilirubin (bil) ≤1.5-fold upper limit of normal value, alanine transaminase (alt) and aspartate aminotransferase (ast) ≤2-fold upper limit of normal value, and serum creatinine (scr) ≤1.5mg/dl;
boolean
C0518015 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Life Expectancy
Item
the expected survival time ＞3 months;
boolean
C0023671 (UMLS CUI [1])
Comprehension Study Protocol | Informed Consent
Item
patients who could understand this study status and had signed the informed consent forms.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Biological Agents
Item
patients who had history of allergic responses to biological agents;
boolean
C1527304 (UMLS CUI [1,1])
C0005515 (UMLS CUI [1,2])
Cancer treatment Other
Item
patients who were receiving other anti-tumor therapies;
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Nidus Measurable Lacking
Item
patients without measureable nidus;
boolean
C1628997 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
CNS metastases Uncontrolled | Organ dysfunction | Heart Diseases Severe | Congestive heart failure | Cardiac Arrhythmia Uncontrolled | Angina Pectoris | Heart valve disease | Myocardial Infarction | Refractory hypertension Requirement Administration of medication Long-term | Wounds Infectious chronic | Psychotic Disorders Uncontrolled | Pregnancy | Breast Feeding
Item
others, including one of the following conditions: patients with uncontrolled central nervous system (cns) metastatic nidi, with dysfunction of important organs and severe cardiac diseases (congestive heart failure, uncontrollable arrhythmia, and angina pectoris, valvular heart disease, myocardial infarction and refractory hypertension that required long-term drug administration), with chronic infectious wound and with history of uncontrollable psychosis, and women in pregnant or lactation period.
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0349410 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0002962 (UMLS CUI [6])
C0018824 (UMLS CUI [7])
C0027051 (UMLS CUI [8])
C0860493 (UMLS CUI [9,1])
C1514873 (UMLS CUI [9,2])
C3469597 (UMLS CUI [9,3])
C0443252 (UMLS CUI [9,4])
C0043250 (UMLS CUI [10,1])
C0009450 (UMLS CUI [10,2])
C0205191 (UMLS CUI [10,3])
C0033975 (UMLS CUI [11,1])
C0205318 (UMLS CUI [11,2])
C0032961 (UMLS CUI [12])
C0006147 (UMLS CUI [13])
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