0 Avaliações
ID

39089

Descrição

R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B; ODM derived from: https://clinicaltrials.gov/show/NCT01852435

Link

https://clinicaltrials.gov/show/NCT01852435

Palavras-chave

Versões (1)
  1. 30/11/2019 30/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

30 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Diffuse Large B-cell Lymphoma NCT01852435

    Inglês

    Eligibility Diffuse Large B-cell Lymphoma NCT01852435

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. histologically confirmed de novo diffuse large b-cell lymphoma or follicular lymphoma grade 3b
    Descrição

    Diffuse Large B-Cell Lymphoma de novo | Follicular Lymphoma Ann Arbor lymphoma staging system

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744
    UMLS CUI [1,2]
    C1515568
    UMLS CUI [2,1]
    C0024301
    UMLS CUI [2,2]
    C0432516
    2. age>=16 y.o.,<=80 y.o.
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. ecog < 3
    Descrição

    ECOG performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    4. no past history of malignancy
    Descrição

    Malignant Neoplasm Absent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0332197
    5. radiologically measurable disease, ct imaging in screening showing 2 or more clearly demarcated lesions with a largest diameter > 1.5 cm, or 1 clearly demarcated lesion with a largest diameter > 2.0 cm.
    Descrição

    Measurable Disease | Lesion Quantity CT | Lesion Longest Diameter

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C1265611
    UMLS CUI [2,3]
    C0040405
    UMLS CUI [3,1]
    C0221198
    UMLS CUI [3,2]
    C0552406
    6. life expectancy>6 months
    Descrição

    Life Expectancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    7. informed consented
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. chemotherapy before
    Descrição

    Chemotherapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    2. bone marrow transplantation before
    Descrição

    Bone Marrow Transplantation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005961
    3. history of malignancy
    Descrição

    Malignant Neoplasms

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    4. active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
    Descrição

    Communicable Disease Requirement Antibiotics General | Communicable Disease Requirement Antifungal therapy | Communicable Disease Requirement Antiviral Therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0003232
    UMLS CUI [1,4]
    C0205246
    UMLS CUI [2,1]
    C0009450
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0678026
    UMLS CUI [3,1]
    C0009450
    UMLS CUI [3,2]
    C1514873
    UMLS CUI [3,3]
    C0280274
    5. uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
    Descrição

    Cardiovascular Disease Uncontrolled | Cerebrovascular Disorder Uncontrolled | Blood Coagulation Disorder Uncontrolled | Autoimmune Disease Uncontrolled | Communicable Disease Serious Uncontrolled

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C0007820
    UMLS CUI [2,2]
    C0205318
    UMLS CUI [3,1]
    C0005779
    UMLS CUI [3,2]
    C0205318
    UMLS CUI [4,1]
    C0004364
    UMLS CUI [4,2]
    C0205318
    UMLS CUI [5,1]
    C0009450
    UMLS CUI [5,2]
    C0205404
    UMLS CUI [5,3]
    C0205318
    6. primary cutaneous, cns, mediastinal dlbcl
    Descrição

    Primary cutaneous diffuse large cell B-cell lymphoma | Diffuse large B-cell lymphoma of central nervous system | Mediastinal (Thymic) Large B-Cell Lymphoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1275325
    UMLS CUI [2]
    C2026186
    UMLS CUI [3]
    C1292754
    7. lvef≤50%
    Descrição

    Left ventricular ejection fraction

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    8. other uncontrollable medical condition that may that may interfere the participation of the study
    Descrição

    Other medical condition Uncontrolled Interferes with Study Subject Participation Status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [1,3]
    C0521102
    UMLS CUI [1,4]
    C2348568
    9. lab at enrollment(unless caused by lymphoma)
    Descrição

    Laboratory test finding | Exception Caused by Lymphoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0587081
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0015127
    UMLS CUI [2,3]
    C0024299
    neutrophile<1.5*10^9/l
    Descrição

    Neutrophil count

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0200633
    platelet<80*10^9/l
    Descrição

    Platelet Count measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    hemoglobulin<100g/l
    Descrição

    Hemoglobin measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    alt or ast >2*uln,akp or bilirubin >1.5*uln
    Descrição

    Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Serum bilirubin increased

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0151905
    UMLS CUI [2]
    C0151904
    UMLS CUI [3]
    C0151849
    UMLS CUI [4]
    C0859062
    creatinine>1.5*uln
    Descrição

    Creatinine increased

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0151578
    10. not able to comply to the protocol for mental or other unknown reasons
    Descrição

    Protocol Compliance Unable | Etiology Mental condition | Reason unknown

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C1299582
    UMLS CUI [2,1]
    C0015127
    UMLS CUI [2,2]
    C3840291
    UMLS CUI [3]
    C3840856
    11. pregnant or lactation
    Descrição

    Pregnancy | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    12. active liver or biliary disease
    Descrição

    Liver disease | Biliary Tract Disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    UMLS CUI [2]
    C0005424
    13. if hbsag positive, should check hbv dna, dna positive patients cannot be enrolled. if hbsag negative but hbcab positive (whatever hbsab status), should check hbv dna,dna positive patients cannot be enrolled.
    Descrição

    HbsAg positive Hbv DNA Test | Hepatitis B DNA assay positive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0149709
    UMLS CUI [1,2]
    C1256114
    UMLS CUI [2]
    C1168040
    14. hiv infection
    Descrição

    HIV Infection

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019693
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    Similar models

    Eligibility Diffuse Large B-cell Lymphoma NCT01852435

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diffuse Large B-Cell Lymphoma de novo | Follicular Lymphoma Ann Arbor lymphoma staging system
    Item
    1. histologically confirmed de novo diffuse large b-cell lymphoma or follicular lymphoma grade 3b
    boolean
    C0079744 (UMLS CUI [1,1])
    C1515568 (UMLS CUI [1,2])
    C0024301 (UMLS CUI [2,1])
    C0432516 (UMLS CUI [2,2])
    Age
    Item
    2. age>=16 y.o.,<=80 y.o.
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    3. ecog < 3
    boolean
    C1520224 (UMLS CUI [1])
    Malignant Neoplasm Absent
    Item
    4. no past history of malignancy
    boolean
    C0006826 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Measurable Disease | Lesion Quantity CT | Lesion Longest Diameter
    Item
    5. radiologically measurable disease, ct imaging in screening showing 2 or more clearly demarcated lesions with a largest diameter > 1.5 cm, or 1 clearly demarcated lesion with a largest diameter > 2.0 cm.
    boolean
    C1513041 (UMLS CUI [1])
    C0221198 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    C0040405 (UMLS CUI [2,3])
    C0221198 (UMLS CUI [3,1])
    C0552406 (UMLS CUI [3,2])
    Life Expectancy
    Item
    6. life expectancy>6 months
    boolean
    C0023671 (UMLS CUI [1])
    Informed Consent
    Item
    7. informed consented
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Chemotherapy
    Item
    1. chemotherapy before
    boolean
    C0392920 (UMLS CUI [1])
    Bone Marrow Transplantation
    Item
    2. bone marrow transplantation before
    boolean
    C0005961 (UMLS CUI [1])
    Malignant Neoplasms
    Item
    3. history of malignancy
    boolean
    C0006826 (UMLS CUI [1])
    Communicable Disease Requirement Antibiotics General | Communicable Disease Requirement Antifungal therapy | Communicable Disease Requirement Antiviral Therapy
    Item
    4. active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
    boolean
    C0009450 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0003232 (UMLS CUI [1,3])
    C0205246 (UMLS CUI [1,4])
    C0009450 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0678026 (UMLS CUI [2,3])
    C0009450 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    C0280274 (UMLS CUI [3,3])
    Cardiovascular Disease Uncontrolled | Cerebrovascular Disorder Uncontrolled | Blood Coagulation Disorder Uncontrolled | Autoimmune Disease Uncontrolled | Communicable Disease Serious Uncontrolled
    Item
    5. uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
    boolean
    C0007222 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0007820 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    C0005779 (UMLS CUI [3,1])
    C0205318 (UMLS CUI [3,2])
    C0004364 (UMLS CUI [4,1])
    C0205318 (UMLS CUI [4,2])
    C0009450 (UMLS CUI [5,1])
    C0205404 (UMLS CUI [5,2])
    C0205318 (UMLS CUI [5,3])
    Primary cutaneous diffuse large cell B-cell lymphoma | Diffuse large B-cell lymphoma of central nervous system | Mediastinal (Thymic) Large B-Cell Lymphoma
    Item
    6. primary cutaneous, cns, mediastinal dlbcl
    boolean
    C1275325 (UMLS CUI [1])
    C2026186 (UMLS CUI [2])
    C1292754 (UMLS CUI [3])
    Left ventricular ejection fraction
    Item
    7. lvef≤50%
    boolean
    C0428772 (UMLS CUI [1])
    Other medical condition Uncontrolled Interferes with Study Subject Participation Status
    Item
    8. other uncontrollable medical condition that may that may interfere the participation of the study
    boolean
    C3843040 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0521102 (UMLS CUI [1,3])
    C2348568 (UMLS CUI [1,4])
    Laboratory test finding | Exception Caused by Lymphoma
    Item
    9. lab at enrollment(unless caused by lymphoma)
    boolean
    C0587081 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0015127 (UMLS CUI [2,2])
    C0024299 (UMLS CUI [2,3])
    Neutrophil count
    Item
    neutrophile<1.5*10^9/l
    boolean
    C0200633 (UMLS CUI [1])
    Platelet Count measurement
    Item
    platelet<80*10^9/l
    boolean
    C0032181 (UMLS CUI [1])
    Hemoglobin measurement
    Item
    hemoglobulin<100g/l
    boolean
    C0518015 (UMLS CUI [1])
    Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Serum bilirubin increased
    Item
    alt or ast >2*uln,akp or bilirubin >1.5*uln
    boolean
    C0151905 (UMLS CUI [1])
    C0151904 (UMLS CUI [2])
    C0151849 (UMLS CUI [3])
    C0859062 (UMLS CUI [4])
    Creatinine increased
    Item
    creatinine>1.5*uln
    boolean
    C0151578 (UMLS CUI [1])
    Protocol Compliance Unable | Etiology Mental condition | Reason unknown
    Item
    10. not able to comply to the protocol for mental or other unknown reasons
    boolean
    C0525058 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    C0015127 (UMLS CUI [2,1])
    C3840291 (UMLS CUI [2,2])
    C3840856 (UMLS CUI [3])
    Pregnancy | Breast Feeding
    Item
    11. pregnant or lactation
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Liver disease | Biliary Tract Disease
    Item
    12. active liver or biliary disease
    boolean
    C0023895 (UMLS CUI [1])
    C0005424 (UMLS CUI [2])
    HbsAg positive Hbv DNA Test | Hepatitis B DNA assay positive
    Item
    13. if hbsag positive, should check hbv dna, dna positive patients cannot be enrolled. if hbsag negative but hbcab positive (whatever hbsab status), should check hbv dna,dna positive patients cannot be enrolled.
    boolean
    C0149709 (UMLS CUI [1,1])
    C1256114 (UMLS CUI [1,2])
    C1168040 (UMLS CUI [2])
    HIV Infection
    Item
    14. hiv infection
    boolean
    C0019693 (UMLS CUI [1])
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