ID

18421

Beschrijving

Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT00184002

Link

https://clinicaltrials.gov/show/NCT00184002

Trefwoorden

Versies (1)
  1. 04-11-16 04-11-16 -
Geüploaded op

4 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT00184002

Engels

Eligibility Non-Hodgkin's Lymphoma NCT00184002

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic diagnosis of non-hodgkin's lymphoma of b-cell origin: follicular large cell, diffuse large cell (including all b-cell variants), burkitt or burkitt-like lymphoma
Beschrijving

B-Cell Lymphomas | Lymphoma, Large-Cell, Follicular | adult diffuse large cell lymphoma | Diffuse Large B-Cell Lymphoma | Burkitt Lymphoma | Burkitt-like lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0079731
UMLS CUI [2]
C0079745
UMLS CUI [3]
C0278762
UMLS CUI [4]
C0079744
UMLS CUI [5]
C0006413
UMLS CUI [6]
C1368771
all stages of disease
Beschrijving

TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
measurable or evaluable tumor parameter(s)
Beschrijving

Neoplasm parameter Measurable | Neoplasm parameter Evaluable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0449381
UMLS CUI [1,3]
C1513040
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0449381
UMLS CUI [2,3]
C0220825
age greater than 17 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status greater or equal to 50%
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
agc greater or equal to 1.0; platelets greater or equal to 75,000(unless abnormal because of lymphoma)
Beschrijving

Absolute neutrophil count | Platelet Count measurement | Abnormal platelets Due to Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3,1]
C0151854
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0024299
bilirubin less or equal to 2.0; sgot less or equal to 3 times upper limit of normal (unless abnormal because of lymphoma)
Beschrijving

Serum total bilirubin measurement | Aspartate aminotransferase measurement | AST/SGOT level abnormal Due to Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3,1]
C0580475
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0024299
creatinine less or equal to 2.0 or creatinine clearance greater or equal to 60 ml/min (unless abnormal because of lymphoma)
Beschrijving

Creatinine measurement, serum | Creatinine clearance measurement | Serum creatinine abnormal Due to Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
UMLS CUI [3,1]
C0438243
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0024299
lvef greater or equal to 45%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
concurrent rt with or without steroids for emergency conditions secondary to lymphoma (i.e., cns tumor, cord compression)are permitted
Beschrijving

Therapeutic radiology procedure | Steroids | Emergency Situation Secondary to Lymphoma | Central Nervous System Neoplasms | Compression of spinal cord

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0038317
UMLS CUI [3,1]
C0013956
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0024299
UMLS CUI [4]
C0085136
UMLS CUI [5]
C0037926
men and women of childbearing potential must agree to use adequate birth control for the duration of the therapy and for 3 months after completion of therapy
Beschrijving

Fertility Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic cytotoxic therapy or rt for lymphoma
Beschrijving

systemic therapy cytotoxic Lymphoma | prior radiation therapy Lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1511636
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0024299
second active tumor, other than non-melanomatous skin ca and in-situ cervical cancer
Beschrijving

Neoplasms, Second Primary | Skin carcinoma | Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
hiv seropositive
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
primary cns lymphoma
Beschrijving

Primary central nervous system lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0280803
pregnant or nursing women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
unable to comply with the requirements of the protocol, or unable to provide adequate informed consent, in the opinion of the pi
Beschrijving

Protocol Compliance Unable | Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00184002

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
B-Cell Lymphomas | Lymphoma, Large-Cell, Follicular | adult diffuse large cell lymphoma | Diffuse Large B-Cell Lymphoma | Burkitt Lymphoma | Burkitt-like lymphoma
Item
pathologic diagnosis of non-hodgkin's lymphoma of b-cell origin: follicular large cell, diffuse large cell (including all b-cell variants), burkitt or burkitt-like lymphoma
boolean
C0079731 (UMLS CUI [1])
C0079745 (UMLS CUI [2])
C0278762 (UMLS CUI [3])
C0079744 (UMLS CUI [4])
C0006413 (UMLS CUI [5])
C1368771 (UMLS CUI [6])
TNM clinical staging
Item
all stages of disease
boolean
C3258246 (UMLS CUI [1])
Neoplasm parameter Measurable | Neoplasm parameter Evaluable
Item
measurable or evaluable tumor parameter(s)
boolean
C0027651 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0449381 (UMLS CUI [2,2])
C0220825 (UMLS CUI [2,3])
Age
Item
age greater than 17 years old
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status greater or equal to 50%
boolean
C0206065 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Abnormal platelets Due to Lymphoma
Item
agc greater or equal to 1.0; platelets greater or equal to 75,000(unless abnormal because of lymphoma)
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0151854 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0024299 (UMLS CUI [3,3])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | AST/SGOT level abnormal Due to Lymphoma
Item
bilirubin less or equal to 2.0; sgot less or equal to 3 times upper limit of normal (unless abnormal because of lymphoma)
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0580475 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0024299 (UMLS CUI [3,3])
Creatinine measurement, serum | Creatinine clearance measurement | Serum creatinine abnormal Due to Lymphoma
Item
creatinine less or equal to 2.0 or creatinine clearance greater or equal to 60 ml/min (unless abnormal because of lymphoma)
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0438243 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0024299 (UMLS CUI [3,3])
Left ventricular ejection fraction
Item
lvef greater or equal to 45%
boolean
C0428772 (UMLS CUI [1])
Therapeutic radiology procedure | Steroids | Emergency Situation Secondary to Lymphoma | Central Nervous System Neoplasms | Compression of spinal cord
Item
concurrent rt with or without steroids for emergency conditions secondary to lymphoma (i.e., cns tumor, cord compression)are permitted
boolean
C1522449 (UMLS CUI [1])
C0038317 (UMLS CUI [2])
C0013956 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0024299 (UMLS CUI [3,3])
C0085136 (UMLS CUI [4])
C0037926 (UMLS CUI [5])
Fertility Contraceptive methods
Item
men and women of childbearing potential must agree to use adequate birth control for the duration of the therapy and for 3 months after completion of therapy
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
systemic therapy cytotoxic Lymphoma | prior radiation therapy Lymphoma
Item
prior systemic cytotoxic therapy or rt for lymphoma
boolean
C1515119 (UMLS CUI [1,1])
C1511636 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
Neoplasms, Second Primary | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
second active tumor, other than non-melanomatous skin ca and in-situ cervical cancer
boolean
C0085183 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
HIV Seropositivity
Item
hiv seropositive
boolean
C0019699 (UMLS CUI [1])
Primary central nervous system lymphoma
Item
primary cns lymphoma
boolean
C0280803 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Protocol Compliance Unable | Informed Consent Unable
Item
unable to comply with the requirements of the protocol, or unable to provide adequate informed consent, in the opinion of the pi
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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