ID

32478

Descrizione

Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01007526

collegamento

https://clinicaltrials.gov/show/NCT01007526

Keywords

versioni (1)
  1. 02/11/18 02/11/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

2 novembre 2018

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Stage I/II Extranodal NK/T-cell Lymphoma NCT01007526

Inglese

Eligibility Stage I/II Extranodal NK/T-cell Lymphoma NCT01007526

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

Nasal Type Extranodal NK/T-Cell Lymphoma

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0392788
at least 18 years old
Descrizione

Age

Tipo di dati

boolean

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

Ann Arbor lymphoma staging system

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0432516
measurable disease
Descrizione

Measurable Disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1513041
eastern cooperative oncology group (ecog) performance status of 0-2
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy greater than 12 weeks
Descrizione

Life Expectancy

Tipo di dati

boolean

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

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

Tipo di dati

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)
Descrizione

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Tipo di dati

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
Descrizione

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement

Tipo di dati

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+, positive for cytotoxic molecules, positive for ebv by in situ hybridization).
Descrizione

Feature Histologic Consistent with Extranodal NK-T-Cell Lymphoma | Immunophenotype Histologic Consistent with Extranodal NK-T-Cell Lymphoma | Cytoplasmic CD3 Positive In Situ Hybridization | Cytoplasmic CD20 Negative In Situ Hybridization | Cytoplasmic Cell positive for CD56 antigen In Situ Hybridization | Molecule Cytotoxic Positive In Situ Hybridization | EBV Positive In Situ Hybridization

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1521970
UMLS CUI [1,2]
C0205462
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C1955906
UMLS CUI [2,1]
C0079611
UMLS CUI [2,2]
C0205462
UMLS CUI [2,3]
C0332290
UMLS CUI [2,4]
C1955906
UMLS CUI [3,1]
C0521449
UMLS CUI [3,2]
C4329510
UMLS CUI [3,3]
C0162788
UMLS CUI [4,1]
C0521449
UMLS CUI [4,2]
C4527200
UMLS CUI [4,3]
C0162788
UMLS CUI [5,1]
C0521449
UMLS CUI [5,2]
C0882903
UMLS CUI [5,3]
C0162788
UMLS CUI [6,1]
C0567416
UMLS CUI [6,2]
C1511636
UMLS CUI [6,3]
C1514241
UMLS CUI [6,4]
C0162788
UMLS CUI [7,1]
C4329796
UMLS CUI [7,2]
C0162788
informed consent
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior or concomitant malignant tumors
Descrizione

Malignant Neoplasms

Tipo di dati

boolean

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

Comorbidity Severe Preventing Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0525058
enktl with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.
Descrizione

Extranodal NK-T-Cell Lymphoma Skin | Extranodal NK-T-Cell Lymphoma Gastrointestinal tract

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1955906
UMLS CUI [1,2]
C1123023
UMLS CUI [2,1]
C1955906
UMLS CUI [2,2]
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.
Descrizione

Non-Hodgkin Lymphoma Subtype | Leukemia, Myelocytic, Acute | Natural Killer Cell Lymphoblastic Leukemia/Lymphoma | Aggressive natural killer-cell leukemia | Peripheral T-Cell Lymphoma

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0449560
UMLS CUI [2]
C0023467
UMLS CUI [3]
C2826059
UMLS CUI [4]
C1292777
UMLS CUI [5]
C0079774
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Similar models

Eligibility Stage I/II Extranodal NK/T-cell Lymphoma NCT01007526

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Nasal Type Extranodal NK/T-Cell Lymphoma
Item
patients were required to have a biopsy-proven diagnosis of nasal enktl
boolean
C0392788 (UMLS CUI [1])
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
Item
eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than 12 weeks
boolean
C0023671 (UMLS CUI [1])
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 Consistent with Extranodal NK-T-Cell Lymphoma | Immunophenotype Histologic Consistent with Extranodal NK-T-Cell Lymphoma | Cytoplasmic CD3 Positive In Situ Hybridization | Cytoplasmic CD20 Negative In Situ Hybridization | Cytoplasmic Cell positive for CD56 antigen In Situ Hybridization | Molecule Cytotoxic Positive In Situ Hybridization | EBV Positive In Situ Hybridization
Item
diagnosis of enktl is based on the presence of histological features and immunophenotypes compatible with enktl (e.g., cytoplasmic cd3+, cd20-, cd56+, positive for cytotoxic molecules, positive for ebv by in situ hybridization).
boolean
C1521970 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C1955906 (UMLS CUI [1,4])
C0079611 (UMLS CUI [2,1])
C0205462 (UMLS CUI [2,2])
C0332290 (UMLS CUI [2,3])
C1955906 (UMLS CUI [2,4])
C0521449 (UMLS CUI [3,1])
C4329510 (UMLS CUI [3,2])
C0162788 (UMLS CUI [3,3])
C0521449 (UMLS CUI [4,1])
C4527200 (UMLS CUI [4,2])
C0162788 (UMLS CUI [4,3])
C0521449 (UMLS CUI [5,1])
C0882903 (UMLS CUI [5,2])
C0162788 (UMLS CUI [5,3])
C0567416 (UMLS CUI [6,1])
C1511636 (UMLS CUI [6,2])
C1514241 (UMLS CUI [6,3])
C0162788 (UMLS CUI [6,4])
C4329796 (UMLS CUI [7,1])
C0162788 (UMLS CUI [7,2])
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])
Comorbidity Severe Preventing Protocol Compliance
Item
any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Extranodal NK-T-Cell Lymphoma Skin | Extranodal NK-T-Cell Lymphoma Gastrointestinal tract
Item
enktl with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.
boolean
C1955906 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
C1955906 (UMLS CUI [2,1])
C0017189 (UMLS CUI [2,2])
Non-Hodgkin Lymphoma Subtype | Leukemia, Myelocytic, Acute | 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])
C0023467 (UMLS CUI [2])
C2826059 (UMLS CUI [3])
C1292777 (UMLS CUI [4])
C0079774 (UMLS CUI [5])
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