ID

21761

Beschrijving

Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00418535

Link

https://clinicaltrials.gov/show/NCT00418535

Trefwoorden

Versies (1)
  1. 28-04-17 28-04-17 -
Geüploaded op

28 april 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphoma, T-Cell NCT00418535

Engels

Eligibility Lymphoma, T-Cell NCT00418535

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed nk/t-cell lymphoma
Beschrijving

Mature NK/T-cell lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0079774
localized (ann arbor stage i/ii) disease
Beschrijving

Localized disease Ann Arbor lymphoma staging system

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277565
UMLS CUI [1,2]
C0432516
at least one measurable lesion
Beschrijving

Measurable Disease Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
age > 18
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0 - 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
expected life span of at least 12 weeks
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
normal marrow function (hemoglobin ≥ 9.0 g/dl; absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3)
Beschrijving

Bone Marrow function | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
normal liver function (total bilirubin < 2x upper limit of normal [uln], transaminase < 3x uln)
Beschrijving

Liver function | Serum total bilirubin measurement | Transaminases

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0002594
normal renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min)
Beschrijving

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ
Beschrijving

Malignant Neoplasms | Skin carcinoma Treated | Carcinoma in situ of uterine cervix Treated

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0851140
UMLS CUI [3,2]
C1522326
serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure)
Beschrijving

Illness Serious | Congestive heart failure | Angina Pectoris | Respiratory Failure | Kidney Failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0002962
UMLS CUI [4]
C1145670
UMLS CUI [5]
C0035078
acute or active infection requiring intravenous (iv) antibiotics
Beschrijving

Communicable Disease Requirement Intravenous antibiotic therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0559680
pregnant, lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous history of chemotherapy or radiotherapy
Beschrijving

Chemotherapy | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
concomitant medication that may influence the study drugs
Beschrijving

Pharmaceutical Preparations Affecting Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0013230
allergic reaction to study drugs
Beschrijving

Allergic Reaction Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0013230
grade 2 or greater peripheral neuropathy
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
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Similar models

Eligibility Lymphoma, T-Cell NCT00418535

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Mature NK/T-cell lymphoma
Item
pathologically confirmed nk/t-cell lymphoma
boolean
C0079774 (UMLS CUI [1])
Localized disease Ann Arbor lymphoma staging system
Item
localized (ann arbor stage i/ii) disease
boolean
C0277565 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Measurable Disease Quantity
Item
at least one measurable lesion
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Age
Item
age > 18
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0 - 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
expected life span of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement
Item
normal marrow function (hemoglobin ≥ 9.0 g/dl; absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Transaminases
Item
normal liver function (total bilirubin < 2x upper limit of normal [uln], transaminase < 3x uln)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
normal renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Skin carcinoma Treated | Carcinoma in situ of uterine cervix Treated
Item
other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Illness Serious | Congestive heart failure | Angina Pectoris | Respiratory Failure | Kidney Failure
Item
serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure)
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C1145670 (UMLS CUI [4])
C0035078 (UMLS CUI [5])
Communicable Disease Requirement Intravenous antibiotic therapy
Item
acute or active infection requiring intravenous (iv) antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0559680 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant, lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure
Item
previous history of chemotherapy or radiotherapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Pharmaceutical Preparations Affecting Investigational New Drugs
Item
concomitant medication that may influence the study drugs
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Allergic Reaction Investigational New Drugs
Item
allergic reaction to study drugs
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Peripheral Neuropathy CTCAE Grades
Item
grade 2 or greater peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
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