ID

41242

Beschreibung

MESA Treatment for NK/T Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01933282

Link

https://clinicaltrials.gov/show/NCT01933282

Stichworte

Versionen (1)
  1. 23.07.20 23.07.20 -
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See clinicaltrials.gov

Hochgeladen am

23. Juli 2020

DOI

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Eligibility Lymphoma, Extranodal NK-T-Cell NCT01933282

Englisch

Eligibility Lymphoma, Extranodal NK-T-Cell NCT01933282

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathological diagnosis is nk/t cell lymphoma；
Beschreibung

Lymphoma, Extranodal NK-T-Cell

Datentyp

boolean

Alias
UMLS CUI [1]
C1955906
at least one objective evaluation ( measurable ) lesions
Beschreibung

Measurable lesion Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
age 15 ~ 60 years old, men and women are not limited
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog(eastern cooperative oncology group）performance status 0~3，expected to survive more than 3 months;
Beschreibung

ECOG performance status | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
heart, kidney function in the normal range
Beschreibung

Cardiac function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0232804
liver function: transminase< 2 times the normal value
Beschreibung

Liver function | Transaminases Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2,1]
C0002594
UMLS CUI [2,2]
C0242485
pregnancy tests of women childbearing age must be negative; men and women agree to use effective contraception during the treatment and the following year
Beschreibung

Childbearing Potential Pregnancy test negative | Agreement Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C0680240
UMLS CUI [2,2]
C0700589
before the test sign the written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the early use of methotrexate or/and l-asparaginase;
Beschreibung

methotrexate | asparaginase

Datentyp

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0003993
pregnant or nursing, psychiatric patients complicated with malignant tumor
Beschreibung

Pregnancy | Breast Feeding | Mental disorder Complicated Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0231242
UMLS CUI [3,3]
C0006826
at the same time the application of other trial drug, drug contraindications exist in research;
Beschreibung

Investigational New Drugs | Pharmaceutical Preparations Contraindicated Research

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444657
UMLS CUI [2,3]
C0035168
serious infection or metabolic diseases
Beschreibung

Communicable Disease Serious | Metabolic Diseases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0025517
liver dysfunction, serum direct bilirubin, indirect bilirubin, transaminase 2 times higher than normal; serum total protein or albumin below normal;
Beschreibung

Liver Dysfunction | Direct bilirubin increased | Bilirubin unconjugated increased | Transaminases increased | Serum total protein decreased | Albumin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0740434
UMLS CUI [3]
C0740435
UMLS CUI [4]
C0438717
UMLS CUI [5]
C0860703
UMLS CUI [6]
C0201838
renal insufficiency, creatinine clearance rate was 2 times higher than normal, especially the creatinine clearance rate is less than 30ml/min;
Beschreibung

Renal Insufficiency | Creatinine renal clearance increased

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0919713
before entering the group, blood: white blood cell< 3×10e9/l; absolute neutrophil count<1.5×10e9/l; platelet<100×10e9/l ( bone marrow is not violated ); platelet count <75×10e9/l ( bone marrow invasion ); hemoglobin<100g/l.
Beschreibung

White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Bone Marrow Invasion | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C1269955
UMLS CUI [5]
C0518015
in the 6 months before entering the group, patients with uncontrolled or serious cardiovascular diseases, including myocardial infarction, iii-iv class heart failure, uncontrolled angina or clinically significant pericardial disease, and diabetes and phlebitis;
Beschreibung

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Serious | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Disorder of pericardium | Diabetes Mellitus | Phlebitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1275491
UMLS CUI [5,1]
C0002962
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0265122
UMLS CUI [7]
C0011849
UMLS CUI [8]
C0031542
hiv antibody positive, hbsag positive after antiviral hbv(hepatitis b virus) dna titer in 104copies/ml the following groups. hiv antibody positive, hbsag+ and dna titer in 104copies/ml after antiviral hbv therapy
Beschreibung

HIV antibody positive | Hepatitis B surface antigen positive | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1]
C0920548
UMLS CUI [2]
C0149709
UMLS CUI [3]
C3846158
coagulation abnormalities.
Beschreibung

Abnormality of coagulation

Datentyp

boolean

Alias
UMLS CUI [1]
C1846821
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Ähnliche Modelle

Eligibility Lymphoma, Extranodal NK-T-Cell NCT01933282

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Extranodal NK-T-Cell
Item
pathological diagnosis is nk/t cell lymphoma；
boolean
C1955906 (UMLS CUI [1])
Measurable lesion Quantity
Item
at least one objective evaluation ( measurable ) lesions
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Age
Item
age 15 ~ 60 years old, men and women are not limited
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Life Expectancy
Item
ecog(eastern cooperative oncology group）performance status 0~3，expected to survive more than 3 months;
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Cardiac function | Renal function
Item
heart, kidney function in the normal range
boolean
C0232164 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Liver function | Transaminases Measurement
Item
liver function: transminase< 2 times the normal value
boolean
C0232741 (UMLS CUI [1])
C0002594 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative | Agreement Contraceptive methods
Item
pregnancy tests of women childbearing age must be negative; men and women agree to use effective contraception during the treatment and the following year
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0680240 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
before the test sign the written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
methotrexate | asparaginase
Item
the early use of methotrexate or/and l-asparaginase;
boolean
C0025677 (UMLS CUI [1])
C0003993 (UMLS CUI [2])
Pregnancy | Breast Feeding | Mental disorder Complicated Malignant Neoplasms
Item
pregnant or nursing, psychiatric patients complicated with malignant tumor
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0004936 (UMLS CUI [3,1])
C0231242 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
Investigational New Drugs | Pharmaceutical Preparations Contraindicated Research
Item
at the same time the application of other trial drug, drug contraindications exist in research;
boolean
C0013230 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
C0035168 (UMLS CUI [2,3])
Communicable Disease Serious | Metabolic Diseases
Item
serious infection or metabolic diseases
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0025517 (UMLS CUI [2])
Liver Dysfunction | Direct bilirubin increased | Bilirubin unconjugated increased | Transaminases increased | Serum total protein decreased | Albumin measurement
Item
liver dysfunction, serum direct bilirubin, indirect bilirubin, transaminase 2 times higher than normal; serum total protein or albumin below normal;
boolean
C0086565 (UMLS CUI [1])
C0740434 (UMLS CUI [2])
C0740435 (UMLS CUI [3])
C0438717 (UMLS CUI [4])
C0860703 (UMLS CUI [5])
C0201838 (UMLS CUI [6])
Renal Insufficiency | Creatinine renal clearance increased
Item
renal insufficiency, creatinine clearance rate was 2 times higher than normal, especially the creatinine clearance rate is less than 30ml/min;
boolean
C1565489 (UMLS CUI [1])
C0919713 (UMLS CUI [2])
White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Bone Marrow Invasion | Hemoglobin measurement
Item
before entering the group, blood: white blood cell< 3×10e9/l; absolute neutrophil count<1.5×10e9/l; platelet<100×10e9/l ( bone marrow is not violated ); platelet count <75×10e9/l ( bone marrow invasion ); hemoglobin<100g/l.
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C1269955 (UMLS CUI [4,2])
C0518015 (UMLS CUI [5])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Serious | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Disorder of pericardium | Diabetes Mellitus | Phlebitis
Item
in the 6 months before entering the group, patients with uncontrolled or serious cardiovascular diseases, including myocardial infarction, iii-iv class heart failure, uncontrolled angina or clinically significant pericardial disease, and diabetes and phlebitis;
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0002962 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0265122 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
C0031542 (UMLS CUI [8])
HIV antibody positive | Hepatitis B surface antigen positive | Other Coding
Item
hiv antibody positive, hbsag positive after antiviral hbv(hepatitis b virus) dna titer in 104copies/ml the following groups. hiv antibody positive, hbsag+ and dna titer in 104copies/ml after antiviral hbv therapy
boolean
C0920548 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Abnormality of coagulation
Item
coagulation abnormalities.
boolean
C1846821 (UMLS CUI [1])
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