ID

27736

Descripción

Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00727831

Link

https://clinicaltrials.gov/show/NCT00727831

Palabras clave

Versiones (1)
  1. 27/11/17 27/11/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de noviembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chemotherapeutic Agent Toxicity NCT00727831

Inglés

Eligibility Chemotherapeutic Agent Toxicity NCT00727831

1 formularios  
Criteria
Descripción

Criteria

histologically confirmed newly diagnosed primary cns lymphoma (pcnsl)
Descripción

Primary central nervous system lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0280803
previously untreated disease
Descripción

Disease untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332155
diffuse large b-cell lymphoma histology
Descripción

Diffuse Large B-Cell Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079744
must be clinically eligible to receive standard 3 g/m² methotrexate if outside trial
Descripción

Methotrexate Dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
no clinically significant effusions or edema
Descripción

Effusion Absent | Edema Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013687
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0013604
UMLS CUI [2,2]
C0332197
patient characteristics:
Descripción

Client Characteristics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0815172
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
ecog performance status 0-3
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
neutrophils ≥ 1 x 10^9/l
Descripción

Neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
platelet count ≥ 100 x 10^9/l
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
bilirubin < 1.5 times upper limit of normal
Descripción

Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
glomerular filtration rate (initially measured by edta/isotope method) ≥ 50 ml/min
Descripción

Glomerular Filtration Rate EDTA Method

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017654
UMLS CUI [1,2]
C0013618
UMLS CUI [1,3]
C0025663
not pregnant or nursing
Descripción

Pregnancy Absent | Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Descripción

Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception during and for 6 months after completion of study therapy
Descripción

Fertility Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
hiv positivity
Descripción

HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
dementia or neurological dysfunction not considered to be due to the pcnsl
Descripción

Dementia | Neurological Dysfunction | Primary central nervous system lymphoma Uninvolved

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C1709219
UMLS CUI [3,1]
C0280803
UMLS CUI [3,2]
C0205429
other serious or uncontrolled medical conditions
Descripción

Medical condition Serious | Medical condition Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
prior malignancy, except adequately treated nonmelanoma skin cancer or carcinoma in situ
Descripción

Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [3,3]
C1522326
prior concurrent therapy:
Descripción

Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
no prior cytotoxic chemotherapy
Descripción

Cytotoxic Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677881
no concurrent prophylactic antibiotics
Descripción

Prophylactic antibiotic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0362063
no concurrent co-trimoxazole
Descripción

co-trimoxazole

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0041044
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Similar models

Eligibility Chemotherapeutic Agent Toxicity NCT00727831

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Primary central nervous system lymphoma
Item
histologically confirmed newly diagnosed primary cns lymphoma (pcnsl)
boolean
C0280803 (UMLS CUI [1])
Disease untreated
Item
previously untreated disease
boolean
C0012634 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Diffuse Large B-Cell Lymphoma
Item
diffuse large b-cell lymphoma histology
boolean
C0079744 (UMLS CUI [1])
Methotrexate Dose
Item
must be clinically eligible to receive standard 3 g/m² methotrexate if outside trial
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Effusion Absent | Edema Absent
Item
no clinically significant effusions or edema
boolean
C0013687 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0013604 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
ecog performance status 0-3
boolean
C1520224 (UMLS CUI [1])
Neutrophil count
Item
neutrophils ≥ 1 x 10^9/l
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100 x 10^9/l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 1.5 times upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Glomerular Filtration Rate EDTA Method
Item
glomerular filtration rate (initially measured by edta/isotope method) ≥ 50 ml/min
boolean
C0017654 (UMLS CUI [1,1])
C0013618 (UMLS CUI [1,2])
C0025663 (UMLS CUI [1,3])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception during and for 6 months after completion of study therapy
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
HIV Seropositivity
Item
hiv positivity
boolean
C0019699 (UMLS CUI [1])
Dementia | Neurological Dysfunction | Primary central nervous system lymphoma Uninvolved
Item
dementia or neurological dysfunction not considered to be due to the pcnsl
boolean
C0497327 (UMLS CUI [1])
C1709219 (UMLS CUI [2])
C0280803 (UMLS CUI [3,1])
C0205429 (UMLS CUI [3,2])
Medical condition Serious | Medical condition Uncontrolled
Item
other serious or uncontrolled medical conditions
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated
Item
prior malignancy, except adequately treated nonmelanoma skin cancer or carcinoma in situ
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Cytotoxic Chemotherapy
Item
no prior cytotoxic chemotherapy
boolean
C0677881 (UMLS CUI [1])
Prophylactic antibiotic
Item
no concurrent prophylactic antibiotics
boolean
C0362063 (UMLS CUI [1])
co-trimoxazole
Item
no concurrent co-trimoxazole
boolean
C0041044 (UMLS CUI [1])
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