ID

39299

Description

Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01238159

Link

https://clinicaltrials.gov/show/NCT01238159

Keywords

Versions (1)
  1. 12/17/19 12/17/19 -
Copyright Holder

See clinicaltrials.gov

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December 17, 2019

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License

Creative Commons BY 4.0
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Eligibility Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type NCT01238159

English

Eligibility Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type NCT01238159

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients were required to have a biopsy-proven diagnosis of nasal enktl
Description

Nasal Type Extranodal NK/T-Cell Lymphoma Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392788
UMLS CUI [1,2]
C0005558
at least 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ann arbor stage ie or iie
Description

Ann Arbor lymphoma staging system

Data type

boolean

Alias
UMLS CUI [1]
C0432516
measurable disease
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
eastern cooperative oncology group (ecog) performance status of 0-2 life expectancy greater than 12 weeks
Description

ECOG performance status | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
adequate hematologic (hemoglobin > 9.0 g/dl, absolute neutrophil count > 1,500/ul and platelets > 100,000/ul)
Description

Hematologic function | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
renal (serum creatinine < 1.5 mg/dl, creatinine clearance > 50 ml/min)
Description

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
hepatic (total bilirubin < 2 times of upper limit of normal and aspartate transferase < 3 times of upper limit of normal) function
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
diagnosis of enktl is based on the presence of histological features and immunophenotypes compatible with enktl (e.g., cytoplasmic cd3+, cd20-, cd56+,
Description

Feature Histologic Compatible with Nasal Type Extranodal NK/T-Cell Lymphoma | Immunophenotype Histologic Compatible with Nasal Type Extranodal NK/T-Cell Lymphoma | Cytoplasmic CD3 Positive | CD20 Negative | CD56 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C2348519
UMLS CUI [1,2]
C0205462
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C0392788
UMLS CUI [2,1]
C0079611
UMLS CUI [2,2]
C0205462
UMLS CUI [2,3]
C0332290
UMLS CUI [2,4]
C0392788
UMLS CUI [3,1]
C3176950
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C0054946
UMLS CUI [4,2]
C1513916
UMLS CUI [5,1]
C0108754
UMLS CUI [5,2]
C1514241
positive for cytotoxic molecules
Description

Positive Finding Molecule cytotoxic

Data type

boolean

Alias
UMLS CUI [1,1]
C1514241
UMLS CUI [1,2]
C0567416
UMLS CUI [1,3]
C1511636
positive for ebv by in situ hybridization).
Description

Positive Finding Epstein-Barr Virus In Situ Hybridization

Data type

boolean

Alias
UMLS CUI [1,1]
C1514241
UMLS CUI [1,2]
C0014644
UMLS CUI [1,3]
C0162788
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior or concomitant malignant tumors
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
Description

Medical Problem Preventing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
enktl with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.
Description

Nasal Type Extranodal NK/T-Cell Lymphoma In addition to Anatomic Site Other | Nasal Type Extranodal NK/T-Cell Lymphoma In addition to Skin | Nasal Type Extranodal NK/T-Cell Lymphoma In addition to Gastrointestinal tract

Data type

boolean

Alias
UMLS CUI [1,1]
C0392788
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C0205394
UMLS CUI [2,1]
C0392788
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C1123023
UMLS CUI [3,1]
C0392788
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0017189
other subtypes of non-hodgkin lymphoma (nhl), including myeloid/nk cell precursor acute leukemia, blastic nk cell lymphoma/precursor nk cell lymphoblastic leukemia, aggressive nk cell leukemia, and peripheral t cell lymphoma, unspecified, were excluded.
Description

Non-Hodgkin Lymphoma Subtype Other | Blastic NK-cell lymphoma | Natural Killer Cell Lymphoblastic Leukemia/Lymphoma | Aggressive natural killer-cell leukemia | Peripheral T-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0449560
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C1301363
UMLS CUI [3]
C2826059
UMLS CUI [4]
C1292777
UMLS CUI [5]
C0079774
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Similar models

Eligibility Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type NCT01238159

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Nasal Type Extranodal NK/T-Cell Lymphoma Biopsy
Item
patients were required to have a biopsy-proven diagnosis of nasal enktl
boolean
C0392788 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Age
Item
at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Ann Arbor lymphoma staging system
Item
ann arbor stage ie or iie
boolean
C0432516 (UMLS CUI [1])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
ECOG performance status | Life Expectancy
Item
eastern cooperative oncology group (ecog) performance status of 0-2 life expectancy greater than 12 weeks
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Hematologic function | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement
Item
adequate hematologic (hemoglobin > 9.0 g/dl, absolute neutrophil count > 1,500/ul and platelets > 100,000/ul)
boolean
C0221130 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
renal (serum creatinine < 1.5 mg/dl, creatinine clearance > 50 ml/min)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement
Item
hepatic (total bilirubin < 2 times of upper limit of normal and aspartate transferase < 3 times of upper limit of normal) function
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Feature Histologic Compatible with Nasal Type Extranodal NK/T-Cell Lymphoma | Immunophenotype Histologic Compatible with Nasal Type Extranodal NK/T-Cell Lymphoma | Cytoplasmic CD3 Positive | CD20 Negative | CD56 Positive
Item
diagnosis of enktl is based on the presence of histological features and immunophenotypes compatible with enktl (e.g., cytoplasmic cd3+, cd20-, cd56+,
boolean
C2348519 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C0392788 (UMLS CUI [1,4])
C0079611 (UMLS CUI [2,1])
C0205462 (UMLS CUI [2,2])
C0332290 (UMLS CUI [2,3])
C0392788 (UMLS CUI [2,4])
C3176950 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0054946 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
C0108754 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
Positive Finding Molecule cytotoxic
Item
positive for cytotoxic molecules
boolean
C1514241 (UMLS CUI [1,1])
C0567416 (UMLS CUI [1,2])
C1511636 (UMLS CUI [1,3])
Positive Finding Epstein-Barr Virus In Situ Hybridization
Item
positive for ebv by in situ hybridization).
boolean
C1514241 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
C0162788 (UMLS CUI [1,3])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms
Item
prior or concomitant malignant tumors
boolean
C0006826 (UMLS CUI [1])
Medical Problem Preventing Protocol Compliance
Item
any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
boolean
C1254481 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Nasal Type Extranodal NK/T-Cell Lymphoma In addition to Anatomic Site Other | Nasal Type Extranodal NK/T-Cell Lymphoma In addition to Skin | Nasal Type Extranodal NK/T-Cell Lymphoma In addition to Gastrointestinal tract
Item
enktl with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.
boolean
C0392788 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0392788 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C1123023 (UMLS CUI [2,3])
C0392788 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0017189 (UMLS CUI [3,3])
Non-Hodgkin Lymphoma Subtype Other | Blastic NK-cell lymphoma | Natural Killer Cell Lymphoblastic Leukemia/Lymphoma | Aggressive natural killer-cell leukemia | Peripheral T-Cell Lymphoma
Item
other subtypes of non-hodgkin lymphoma (nhl), including myeloid/nk cell precursor acute leukemia, blastic nk cell lymphoma/precursor nk cell lymphoblastic leukemia, aggressive nk cell leukemia, and peripheral t cell lymphoma, unspecified, were excluded.
boolean
C0024305 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1301363 (UMLS CUI [2])
C2826059 (UMLS CUI [3])
C1292777 (UMLS CUI [4])
C0079774 (UMLS CUI [5])
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