ID

41208

Descrizione

Stage I/II Nasal NK Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01321008

collegamento

https://clinicaltrials.gov/show/NCT01321008

Keywords

versioni (1)
  1. 14/07/20 14/07/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

14 luglio 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Lymphoma NCT01321008

Inglese

Eligibility Lymphoma NCT01321008

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01321008
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with newly diagnosed stage i and ii nasal natural killer (nk) cell lymphoma.
Descrizione

Nasal NK/T-cell lymphoma TNM clinical staging

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0558916
UMLS CUI [1,2]
C3258246
2. adequate blood cell counts (i.e. absolute neutrophil count (anc)> 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and epoetin. epoetin will not be administered concurrently with radiation.
Descrizione

Blood Cell Count | Absolute neutrophil count | Transfusion | filgrastim | Erythropoietin | Therapeutic radiology procedure Absent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005771
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0005841
UMLS CUI [4]
C0210630
UMLS CUI [5]
C0014822
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0332197
3. patients must have adequate liver function as indicated by: *bilirubin </= 1.5 times the upper limit of normal (uln), * alanine transaminase (alt) </= 2 times the (uln) or aspartate transaminase (ast) ≤ 2 times the uln, *these values must be obtained within two weeks before protocol entry.
Descrizione

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
4. patients are required to have adequate renal function as indicated by a serum creatinine </= 2.5 mg/dl.this value must be obtained within two weeks before protocol entry.
Descrizione

Renal function | Creatinine measurement, serum

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
5. left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure >/= 50%.
Descrizione

Left ventricular ejection fraction Radionuclide Imaging | Left ventricular ejection fraction Echocardiography

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0034606
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
6. male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
Descrizione

Gender Barrier Contraception | Gender Sexual Abstinence Coitus

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036899
UMLS CUI [2,3]
C0009253
7. female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized).
Descrizione

Gender Barrier Contraception Quantity | Gender Sexual Abstinence Coitus | Postmenopausal state | Female Sterilization

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036899
UMLS CUI [2,3]
C0009253
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
8. female patients of childbearing potential must have a negative serum pregnancy test (bhcg) within 2 weeks of protocol entry.
Descrizione

Childbearing Potential Serum pregnancy test (B-HCG) Negative

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
9. patients must have the ability to give informed consent.
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with active hepatitis b and/or hepatitis c infection.
Descrizione

Hepatitis B | Hepatitis C

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
2. patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
Descrizione

Communicable Disease Requirement Anti-infective therapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1141958
3. patients known to be hiv positive.
Descrizione

HIV Seropositivity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019699
4. patients with pre-existing cardiovascular disease requiring ongoing treatment. this includes: a) congestive heart failure class iii/iv (chf) per new york heart association (nyha) criteria. b) cardiomyopathy, c) uncontrolled cardiac arrhythmia, d) unstable angina pectoris, e) recent myocardial infarction (mi) (within 6 months).
Descrizione

Cardiovascular Disease Treatment required for | Congestive heart failure New York Heart Association Classification | Cardiomyopathy | Cardiac Arrhythmia Uncontrolled | Angina, Unstable | Myocardial Infarction

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0878544
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0027051
5. patients with prior exposure to anthracyclines:
Descrizione

Exposure to Anthracyclines

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0282564
6. patients who are pregnant or breast-feeding.
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
Descrizione

Mental disorders Limiting Medication Compliance | Social situation Limiting Medication Compliance | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C3489773
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C3489773
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0525058
8. prior radiation to the site of current primary disease, if re-treatment would lead to violation of known radiation dose tolerance limits for that site.
Descrizione

Prior Radiation Therapy Site Disease Current

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0521116
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Similar models

Eligibility Lymphoma NCT01321008

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01321008
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Nasal NK/T-cell lymphoma TNM clinical staging
Item
1. patients with newly diagnosed stage i and ii nasal natural killer (nk) cell lymphoma.
boolean
C0558916 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Blood Cell Count | Absolute neutrophil count | Transfusion | filgrastim | Erythropoietin | Therapeutic radiology procedure Absent
Item
2. adequate blood cell counts (i.e. absolute neutrophil count (anc)> 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and epoetin. epoetin will not be administered concurrently with radiation.
boolean
C0005771 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0005841 (UMLS CUI [3])
C0210630 (UMLS CUI [4])
C0014822 (UMLS CUI [5])
C1522449 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
3. patients must have adequate liver function as indicated by: *bilirubin </= 1.5 times the upper limit of normal (uln), * alanine transaminase (alt) </= 2 times the (uln) or aspartate transaminase (ast) ≤ 2 times the uln, *these values must be obtained within two weeks before protocol entry.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
4. patients are required to have adequate renal function as indicated by a serum creatinine </= 2.5 mg/dl.this value must be obtained within two weeks before protocol entry.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Left ventricular ejection fraction Radionuclide Imaging | Left ventricular ejection fraction Echocardiography
Item
5. left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure >/= 50%.
boolean
C0428772 (UMLS CUI [1,1])
C0034606 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Gender Barrier Contraception | Gender Sexual Abstinence Coitus
Item
6. male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C0009253 (UMLS CUI [2,3])
Gender Barrier Contraception Quantity | Gender Sexual Abstinence Coitus | Postmenopausal state | Female Sterilization
Item
7. female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized).
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C0009253 (UMLS CUI [2,3])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
8. female patients of childbearing potential must have a negative serum pregnancy test (bhcg) within 2 weeks of protocol entry.
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Informed Consent
Item
9. patients must have the ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hepatitis B | Hepatitis C
Item
1. patients with active hepatitis b and/or hepatitis c infection.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Communicable Disease Requirement Anti-infective therapy
Item
2. patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1141958 (UMLS CUI [1,3])
HIV Seropositivity
Item
3. patients known to be hiv positive.
boolean
C0019699 (UMLS CUI [1])
Cardiovascular Disease Treatment required for | Congestive heart failure New York Heart Association Classification | Cardiomyopathy | Cardiac Arrhythmia Uncontrolled | Angina, Unstable | Myocardial Infarction
Item
4. patients with pre-existing cardiovascular disease requiring ongoing treatment. this includes: a) congestive heart failure class iii/iv (chf) per new york heart association (nyha) criteria. b) cardiomyopathy, c) uncontrolled cardiac arrhythmia, d) unstable angina pectoris, e) recent myocardial infarction (mi) (within 6 months).
boolean
C0007222 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0878544 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0002965 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
Exposure to Anthracyclines
Item
5. patients with prior exposure to anthracyclines:
boolean
C0332157 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
6. patients who are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental disorders Limiting Medication Compliance | Social situation Limiting Medication Compliance | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
7. patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C3489773 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C3489773 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Prior Radiation Therapy Site Disease Current
Item
8. prior radiation to the site of current primary disease, if re-treatment would lead to violation of known radiation dose tolerance limits for that site.
boolean
C0279134 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
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