ID

20779

Beskrivning

Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00386321

Länk

https://clinicaltrials.gov/show/NCT00386321

Nyckelord

Versioner (1)
  1. 2017-03-16 2017-03-16 -
Uppladdad den

16 mars 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diffuse Large B-cell Lymphoma NCT00386321

Engelsk

Eligibility Diffuse Large B-cell Lymphoma NCT00386321

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed cd20 positive diffuse large b-cell lymphoma with bulky stage ii or stage iii or stage iv
Beskrivning

Diffuse Large B-Cell Lymphoma CD20 positive Bulky Ann Arbor lymphoma staging system

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C3888518
UMLS CUI [1,3]
C1511341
UMLS CUI [1,4]
C0432516
bidimensionally measurable disease
Beskrivning

Measurable Disease 2-Dimensional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
performance status zubrod 0-2
Beskrivning

Zubrod Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C3714786
less than 20,000/mcl circulating lymphoid cells on wbc differential count
Beskrivning

Differential white blood cell count Lymphoid Cells

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162401
UMLS CUI [1,2]
C0086574
no clinical evidence of cns involvement, no prior diagnosis of indolent lymphoma, no histologic transformation
Beskrivning

Central Nervous System Involvement Evidence | indolent lymphoma | Transformation Histologic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C3887511
UMLS CUI [2]
C1334170
UMLS CUI [3,1]
C0040682
UMLS CUI [3,2]
C0205462
ejection fraction more than or equal to 45% by muga or no significant abnormality by echocardiogram
Beskrivning

Ejection fraction Multiple gated acquisition scanning | ECG normal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0489482
UMLS CUI [1,2]
C0521317
UMLS CUI [2]
C0522054
fertile patients with effective contraception method
Beskrivning

Fertility Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, stage i or ii cancer in complete remission, or carcinoma in situ of cervix
Beskrivning

Malignant Neoplasm | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | In complete remission TNM clinical staging | Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0677874
UMLS CUI [4,2]
C3258246
UMLS CUI [5]
C0851140
no hiv positive, no prior solid organ transplantation
Beskrivning

HIV Seropositivity | Solid organ transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0730400
no prior antibody therapy, chemotherapy, radiotherapy for lymphoma
Beskrivning

antibody therapy Lymphoma | Chemotherapy Lymphoma | Therapeutic radiology procedure Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0281176
UMLS CUI [1,2]
C0024299
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0024299
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0024299
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
serum creatinine ot bilirubin more than 2.5 x uln unless due to lymphoma
Beskrivning

Serum creatinine raised | Elevated total bilirubin | Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0700225
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0024299
active uncontrolled infection
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
Beskrivning

Comorbidity Severe compromises Study Subject Participation Status | Comorbidity Uncontrolled compromises Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C2348568
patients with more than 25% infiltrated bone marrow
Beskrivning

Bone marrow infiltration Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3854434
UMLS CUI [1,2]
C0439165
patients with platelet counts less than 100,000/mcl or neutrophil counts less than 1,500/mcl
Beskrivning

Platelet Count measurement | Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0948762
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Similar models

Eligibility Diffuse Large B-cell Lymphoma NCT00386321

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma CD20 positive Bulky Ann Arbor lymphoma staging system
Item
histologically confirmed cd20 positive diffuse large b-cell lymphoma with bulky stage ii or stage iii or stage iv
boolean
C0079744 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C1511341 (UMLS CUI [1,3])
C0432516 (UMLS CUI [1,4])
Measurable Disease 2-Dimensional
Item
bidimensionally measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
Zubrod Performance Status
Item
performance status zubrod 0-2
boolean
C3714786 (UMLS CUI [1])
Differential white blood cell count Lymphoid Cells
Item
less than 20,000/mcl circulating lymphoid cells on wbc differential count
boolean
C0162401 (UMLS CUI [1,1])
C0086574 (UMLS CUI [1,2])
Central Nervous System Involvement Evidence | indolent lymphoma | Transformation Histologic
Item
no clinical evidence of cns involvement, no prior diagnosis of indolent lymphoma, no histologic transformation
boolean
C4050309 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C1334170 (UMLS CUI [2])
C0040682 (UMLS CUI [3,1])
C0205462 (UMLS CUI [3,2])
Ejection fraction Multiple gated acquisition scanning | ECG normal
Item
ejection fraction more than or equal to 45% by muga or no significant abnormality by echocardiogram
boolean
C0489482 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0522054 (UMLS CUI [2])
Fertility Contraceptive methods
Item
fertile patients with effective contraception method
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Malignant Neoplasm | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | In complete remission TNM clinical staging | Carcinoma in situ of uterine cervix
Item
no other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, stage i or ii cancer in complete remission, or carcinoma in situ of cervix
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0677874 (UMLS CUI [4,1])
C3258246 (UMLS CUI [4,2])
C0851140 (UMLS CUI [5])
HIV Seropositivity | Solid organ transplant
Item
no hiv positive, no prior solid organ transplantation
boolean
C0019699 (UMLS CUI [1])
C0730400 (UMLS CUI [2])
antibody therapy Lymphoma | Chemotherapy Lymphoma | Therapeutic radiology procedure Lymphoma
Item
no prior antibody therapy, chemotherapy, radiotherapy for lymphoma
boolean
C0281176 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0024299 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Serum creatinine raised | Elevated total bilirubin | Lymphoma
Item
serum creatinine ot bilirubin more than 2.5 x uln unless due to lymphoma
boolean
C0700225 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
Communicable Disease Uncontrolled
Item
active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Comorbidity Severe compromises Study Subject Participation Status | Comorbidity Uncontrolled compromises Study Subject Participation Status
Item
concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Bone marrow infiltration Percentage
Item
patients with more than 25% infiltrated bone marrow
boolean
C3854434 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Platelet Count measurement | Absolute neutrophil count
Item
patients with platelet counts less than 100,000/mcl or neutrophil counts less than 1,500/mcl
boolean
C0032181 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
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