ID

15408

Beschrijving

Efficacy and Safety Study of P-Gemox vs.EPOCH as First-line Chemotherapy to Treat NK/T-cell Lymphoma With Early Stage; ODM derived from: https://clinicaltrials.gov/show/NCT02359162

Link

https://clinicaltrials.gov/show/NCT02359162

Trefwoorden

Versies (1)
  1. 30-05-16 30-05-16 -
Geüploaded op

30 mei 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphoma, Extranodal NK-T-Cell NCT02359162

Engels

Eligibility Lymphoma, Extranodal NK-T-Cell NCT02359162

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed enktl
Beschrijving

Lymphoma, Extranodal NK-T-Cell

Datatype

boolean

Alias
UMLS CUI [1]
C1955906
age:18-69years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ann arbor stage ie,or stage iie with cervical lymph node involvement
Beschrijving

Ann Arbor lymphoma staging system | Cervical lymph node Involvement with

Datatype

boolean

Alias
UMLS CUI [1]
C0432516
UMLS CUI [2,1]
C1279046
UMLS CUI [2,2]
C1314939
at lease one measurable lesion
Beschrijving

Measurable lesion

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
receive no chemotherapy or radiotherapy before
Beschrijving

Chemotherapy Regimen Firstly | Therapeutic radiology procedure Firstly

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1279901
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1279901
eastern cooperativeoncology group performance status of 0 to 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count
Beschrijving

Hematologic function | White Blood Cell Count procedure | Neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0200633
≥1.5×10e9/l, and platelet count≥ 100×10e9/l),renal function (eg, serum creatinine≤1.5 mg/dl and creatinine clearance ≥50 ml minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)
Beschrijving

Platelet Count measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Liver function | Bilirubin, total measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0373595
UMLS CUI [5]
C0232741
UMLS CUI [6]
C0201913
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201836
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
mismatch the inclusion criteria
Beschrijving

Mismatch Inclusion criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C1881865
UMLS CUI [1,2]
C1512693
systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
Beschrijving

Central Nervous System Involvement systematic | Malignant Neoplasms | Comorbidity Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0220922
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C1321605
UMLS CUI [3,3]
C0439801
primary lesion not from the upper respiratory
Beschrijving

Primary Lesion | Upper respiratory tract

Datatype

boolean

Alias
UMLS CUI [1]
C1402294
UMLS CUI [2]
C0458578
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Similar models

Eligibility Lymphoma, Extranodal NK-T-Cell NCT02359162

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Extranodal NK-T-Cell
Item
newly diagnosed enktl
boolean
C1955906 (UMLS CUI [1])
Age
Item
age:18-69years
boolean
C0001779 (UMLS CUI [1])
Ann Arbor lymphoma staging system | Cervical lymph node Involvement with
Item
ann arbor stage ie,or stage iie with cervical lymph node involvement
boolean
C0432516 (UMLS CUI [1])
C1279046 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
Measurable lesion
Item
at lease one measurable lesion
boolean
C1513041 (UMLS CUI [1])
Chemotherapy Regimen Firstly | Therapeutic radiology procedure Firstly
Item
receive no chemotherapy or radiotherapy before
boolean
C0392920 (UMLS CUI [1,1])
C1279901 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1279901 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperativeoncology group performance status of 0 to 2.
boolean
C1520224 (UMLS CUI [1])
Hematologic function | White Blood Cell Count procedure | Neutrophil count
Item
adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count
boolean
C0221130 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
Platelet Count measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Liver function | Bilirubin, total measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
≥1.5×10e9/l, and platelet count≥ 100×10e9/l),renal function (eg, serum creatinine≤1.5 mg/dl and creatinine clearance ≥50 ml minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)
boolean
C0032181 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
C0201913 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Mismatch Inclusion criteria
Item
mismatch the inclusion criteria
boolean
C1881865 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Central Nervous System Involvement systematic | Malignant Neoplasms | Comorbidity Compliance behavior Limited
Item
systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
boolean
C3714787 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0220922 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2])
C0009488 (UMLS CUI [3,1])
C1321605 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
Primary Lesion | Upper respiratory tract
Item
primary lesion not from the upper respiratory
boolean
C1402294 (UMLS CUI [1])
C0458578 (UMLS CUI [2])
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