ID

44495

Description

Mature B-Cell Lymphoma And Leukemia Study III; ODM derived from: https://clinicaltrials.gov/show/NCT01046825

Link

https://clinicaltrials.gov/show/NCT01046825

Keywords

Versions (3)
  1. 6/15/18 6/15/18 -
  2. 6/15/18 6/15/18 -
  3. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

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September 27, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Mature B-Cell Lymphoma NCT01046825

    English

    Eligibility Mature B-Cell Lymphoma NCT01046825

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    st. jude participants:
    Description

    Study Subject Medical center

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0681850
    UMLS CUI [1,2]
    C0565990
    1. participant must have a histologic diagnosis of a mature b cell lymphoma (e.g., burkitt lymphoma/leukemia, atypical burkitt lymphoma, diffuse large b-cell lymphoma, mediastinal large b-cell lymphoma, mature b-cell lymphoma nos) as defined in the who classification.
    Description

    Mature B-Cell Lymphoma WHO tumor classification | Burkitt Lymphoma | Atypical Burkitt's lymphoma | Diffuse Large B-Cell Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Mature B-Cell Lymphoma NOS

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1334634
    UMLS CUI [1,2]
    C1301142
    UMLS CUI [2]
    C0006413
    UMLS CUI [3]
    C1629504
    UMLS CUI [4]
    C0079744
    UMLS CUI [5]
    C1292754
    UMLS CUI [6,1]
    C1334634
    UMLS CUI [6,2]
    C1518425
    2. participant must be previously untreated, (no more than 72 hours of steroids and/or emergency radiation)
    Description

    Study Subject untreated | Steroids Duration | Emergency Therapeutic radiology procedure Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0681850
    UMLS CUI [1,2]
    C0332155
    UMLS CUI [2,1]
    C0038317
    UMLS CUI [2,2]
    C0449238
    UMLS CUI [3,1]
    C0013956
    UMLS CUI [3,2]
    C1522449
    UMLS CUI [3,3]
    C0449238
    3. participant must be < 22 years of age at the time of diagnosis
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    4. for group b participants with mediastinal large b cell lymphoma (mlbcl) disease only (receiving rituximab) - all participants with mlbcl assigned to group b must have hepatitis screening prior to enrollment. participants whose results indicate that they are carrier of hepatitis b can still be treated per group b but will not receive rituximab. this screening must be done for eligibility but the results are not needed prior to enrollment:
    Description

    Mediastinal (Thymic) Large B-Cell Lymphoma | rituximab | Viral hepatitis screening test | Hepatitis B carrier Rituximab Excluded

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1292754
    UMLS CUI [2]
    C0393022
    UMLS CUI [3]
    C1445958
    UMLS CUI [4,1]
    C0262505
    UMLS CUI [4,2]
    C0393022
    UMLS CUI [4,3]
    C0332196
    hepatitis b immunization status (vaccination yes or no)
    Description

    Hepatitis B Immunization status | Vaccination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019163
    UMLS CUI [1,2]
    C0552506
    UMLS CUI [2]
    C0042196
    hbsag
    Description

    Hepatitis B Surface Antigens

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019168
    anti-hbs antibody
    Description

    Anti-HBs antibody

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201478
    anti-hbc antibody. all participants must have screening prior to enrollment. participants whose results indicate that they are carrier of hepatitis b can still be treated per group b but will not receive rituximab.
    Description

    Anti-HBc antibody | Hepatitis B carrier Rituximab Excluded

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948759
    UMLS CUI [2,1]
    C0262505
    UMLS CUI [2,2]
    C0393022
    UMLS CUI [2,3]
    C0332196
    5. hiv test has been obtained within 42 days. participants who test positive for hiv cannot be enrolled on therapeutic part of study, but are still eligible for biology studies.
    Description

    Human immunodeficiency virus test | HIV Seropositivity Study Therapeutic Excluded

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1321876
    UMLS CUI [2,1]
    C0019699
    UMLS CUI [2,2]
    C2603343
    UMLS CUI [2,3]
    C0302350
    UMLS CUI [2,4]
    C0332196
    6. informed consent must be obtained according to st. jude guidelines before enrollment into study
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    participants from collaborating sites participating in biological objectives only:
    Description

    Collaboration Study Site | Objective biological

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0282116
    UMLS CUI [1,2]
    C2825164
    UMLS CUI [2,1]
    C0018017
    UMLS CUI [2,2]
    C0205460
    1. participant must have a histologic diagnosis of a mature b cell lymphoma (e.g., burkitt lymphoma/leukemia, atypical burkitt lymphoma, diffuse large b-cell lymphoma, mediastinal large b-cell lymphoma, mature b-cell lymphoma nos) as defined in the who classification
    Description

    Mature B-Cell Lymphoma WHO tumor classification | Burkitt Lymphoma | Atypical Burkitt's lymphoma | Diffuse Large B-Cell Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Mature B-Cell Lymphoma NOS

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1334634
    UMLS CUI [1,2]
    C1301142
    UMLS CUI [2]
    C0006413
    UMLS CUI [3]
    C1629504
    UMLS CUI [4]
    C0079744
    UMLS CUI [5]
    C1292754
    UMLS CUI [6,1]
    C1334634
    UMLS CUI [6,2]
    C1518425
    2. participant must be < 22 years of age at the time of diagnosis
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. informed consent must be obtained by local pi or his/her designee according to ich/good clinical practice and local guidelines before enrollment into study
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    participants from collaborating sites participating in therapeutic and biological objectives:
    Description

    Collaboration Study Site | Objective Therapeutic | Objective biological

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0282116
    UMLS CUI [1,2]
    C2825164
    UMLS CUI [2,1]
    C0018017
    UMLS CUI [2,2]
    C0302350
    UMLS CUI [3,1]
    C0018017
    UMLS CUI [3,2]
    C0205460
    1. participants with prior therapy (except steroids or rt)
    Description

    Prior Therapy | Exception Steroids | Exception Therapeutic radiology procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1514463
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0038317
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C1522449
    2. participants known to be hiv positive (for therapeutic part of protocol, hiv participants are eligible for biology studies).
    Description

    HIV Seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    3. participants who are pregnant or lactating
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    4. inability or unwillingness of research participant or legal guardian to consent
    Description

    Informed Consent Unable | Informed Consent Unwilling | Legal Guardian Informed Consent Unable | Legal Guardian Informed Consent Unwilling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0558080
    UMLS CUI [3,1]
    C0023226
    UMLS CUI [3,2]
    C0021430
    UMLS CUI [3,3]
    C1299582
    UMLS CUI [4,1]
    C0023226
    UMLS CUI [4,2]
    C0021430
    UMLS CUI [4,3]
    C0558080
    5. participants who received emergent steroids and/or radiation prior to biopsy may be included in therapeutic part of study, but will be excluded from biology studies.
    Description

    Emergency Steroids | Emergency Therapeutic radiology procedure | Study biological Excluded

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013956
    UMLS CUI [1,2]
    C0038317
    UMLS CUI [2,1]
    C0013956
    UMLS CUI [2,2]
    C1522449
    UMLS CUI [3,1]
    C2603343
    UMLS CUI [3,2]
    C0205460
    UMLS CUI [3,3]
    C0332196
    participants from collaborating sites participating in biological objectives only:
    Description

    Collaboration Study Site | Objective biological

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0282116
    UMLS CUI [1,2]
    C2825164
    UMLS CUI [2,1]
    C0018017
    UMLS CUI [2,2]
    C0205460
    1. inability or unwillingness of research participant or legal guardian to consent
    Description

    Informed Consent Unable | Informed Consent Unwilling | Legal Guardian Informed Consent Unable | Legal Guardian Informed Consent Unwilling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0558080
    UMLS CUI [3,1]
    C0023226
    UMLS CUI [3,2]
    C0021430
    UMLS CUI [3,3]
    C1299582
    UMLS CUI [4,1]
    C0023226
    UMLS CUI [4,2]
    C0021430
    UMLS CUI [4,3]
    C0558080
    2. histologic diagnosis other than a mature b-cell lymphoma as defined in the who classification
    Description

    Histological diagnosis WHO classification | Exception Mature B-Cell Lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0679557
    UMLS CUI [1,2]
    C4267671
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C1334634
    3. participants who received emergent steroids and/or radiation prior to biopsy
    Description

    Emergency Steroids | Emergency Therapeutic radiology procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013956
    UMLS CUI [1,2]
    C0038317
    UMLS CUI [2,1]
    C0013956
    UMLS CUI [2,2]
    C1522449
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    Eligibility Mature B-Cell Lymphoma NCT01046825

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Study Subject Medical center
    Item
    st. jude participants:
    boolean
    C0681850 (UMLS CUI [1,1])
    C0565990 (UMLS CUI [1,2])
    Mature B-Cell Lymphoma WHO tumor classification | Burkitt Lymphoma | Atypical Burkitt's lymphoma | Diffuse Large B-Cell Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Mature B-Cell Lymphoma NOS
    Item
    1. participant must have a histologic diagnosis of a mature b cell lymphoma (e.g., burkitt lymphoma/leukemia, atypical burkitt lymphoma, diffuse large b-cell lymphoma, mediastinal large b-cell lymphoma, mature b-cell lymphoma nos) as defined in the who classification.
    boolean
    C1334634 (UMLS CUI [1,1])
    C1301142 (UMLS CUI [1,2])
    C0006413 (UMLS CUI [2])
    C1629504 (UMLS CUI [3])
    C0079744 (UMLS CUI [4])
    C1292754 (UMLS CUI [5])
    C1334634 (UMLS CUI [6,1])
    C1518425 (UMLS CUI [6,2])
    Study Subject untreated | Steroids Duration | Emergency Therapeutic radiology procedure Duration
    Item
    2. participant must be previously untreated, (no more than 72 hours of steroids and/or emergency radiation)
    boolean
    C0681850 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    C0038317 (UMLS CUI [2,1])
    C0449238 (UMLS CUI [2,2])
    C0013956 (UMLS CUI [3,1])
    C1522449 (UMLS CUI [3,2])
    C0449238 (UMLS CUI [3,3])
    Age
    Item
    3. participant must be < 22 years of age at the time of diagnosis
    boolean
    C0001779 (UMLS CUI [1])
    Mediastinal (Thymic) Large B-Cell Lymphoma | rituximab | Viral hepatitis screening test | Hepatitis B carrier Rituximab Excluded
    Item
    4. for group b participants with mediastinal large b cell lymphoma (mlbcl) disease only (receiving rituximab) - all participants with mlbcl assigned to group b must have hepatitis screening prior to enrollment. participants whose results indicate that they are carrier of hepatitis b can still be treated per group b but will not receive rituximab. this screening must be done for eligibility but the results are not needed prior to enrollment:
    boolean
    C1292754 (UMLS CUI [1])
    C0393022 (UMLS CUI [2])
    C1445958 (UMLS CUI [3])
    C0262505 (UMLS CUI [4,1])
    C0393022 (UMLS CUI [4,2])
    C0332196 (UMLS CUI [4,3])
    Hepatitis B Immunization status | Vaccination
    Item
    hepatitis b immunization status (vaccination yes or no)
    boolean
    C0019163 (UMLS CUI [1,1])
    C0552506 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [2])
    Hepatitis B Surface Antigens
    Item
    hbsag
    boolean
    C0019168 (UMLS CUI [1])
    Anti-HBs antibody
    Item
    anti-hbs antibody
    boolean
    C0201478 (UMLS CUI [1])
    Anti-HBc antibody | Hepatitis B carrier Rituximab Excluded
    Item
    anti-hbc antibody. all participants must have screening prior to enrollment. participants whose results indicate that they are carrier of hepatitis b can still be treated per group b but will not receive rituximab.
    boolean
    C0948759 (UMLS CUI [1])
    C0262505 (UMLS CUI [2,1])
    C0393022 (UMLS CUI [2,2])
    C0332196 (UMLS CUI [2,3])
    Human immunodeficiency virus test | HIV Seropositivity Study Therapeutic Excluded
    Item
    5. hiv test has been obtained within 42 days. participants who test positive for hiv cannot be enrolled on therapeutic part of study, but are still eligible for biology studies.
    boolean
    C1321876 (UMLS CUI [1])
    C0019699 (UMLS CUI [2,1])
    C2603343 (UMLS CUI [2,2])
    C0302350 (UMLS CUI [2,3])
    C0332196 (UMLS CUI [2,4])
    Informed Consent
    Item
    6. informed consent must be obtained according to st. jude guidelines before enrollment into study
    boolean
    C0021430 (UMLS CUI [1])
    Collaboration Study Site | Objective biological
    Item
    participants from collaborating sites participating in biological objectives only:
    boolean
    C0282116 (UMLS CUI [1,1])
    C2825164 (UMLS CUI [1,2])
    C0018017 (UMLS CUI [2,1])
    C0205460 (UMLS CUI [2,2])
    Mature B-Cell Lymphoma WHO tumor classification | Burkitt Lymphoma | Atypical Burkitt's lymphoma | Diffuse Large B-Cell Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Mature B-Cell Lymphoma NOS
    Item
    1. participant must have a histologic diagnosis of a mature b cell lymphoma (e.g., burkitt lymphoma/leukemia, atypical burkitt lymphoma, diffuse large b-cell lymphoma, mediastinal large b-cell lymphoma, mature b-cell lymphoma nos) as defined in the who classification
    boolean
    C1334634 (UMLS CUI [1,1])
    C1301142 (UMLS CUI [1,2])
    C0006413 (UMLS CUI [2])
    C1629504 (UMLS CUI [3])
    C0079744 (UMLS CUI [4])
    C1292754 (UMLS CUI [5])
    C1334634 (UMLS CUI [6,1])
    C1518425 (UMLS CUI [6,2])
    Age
    Item
    2. participant must be < 22 years of age at the time of diagnosis
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent
    Item
    3. informed consent must be obtained by local pi or his/her designee according to ich/good clinical practice and local guidelines before enrollment into study
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Collaboration Study Site | Objective Therapeutic | Objective biological
    Item
    participants from collaborating sites participating in therapeutic and biological objectives:
    boolean
    C0282116 (UMLS CUI [1,1])
    C2825164 (UMLS CUI [1,2])
    C0018017 (UMLS CUI [2,1])
    C0302350 (UMLS CUI [2,2])
    C0018017 (UMLS CUI [3,1])
    C0205460 (UMLS CUI [3,2])
    Prior Therapy | Exception Steroids | Exception Therapeutic radiology procedure
    Item
    1. participants with prior therapy (except steroids or rt)
    boolean
    C1514463 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0038317 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C1522449 (UMLS CUI [3,2])
    HIV Seropositivity
    Item
    2. participants known to be hiv positive (for therapeutic part of protocol, hiv participants are eligible for biology studies).
    boolean
    C0019699 (UMLS CUI [1])
    Pregnancy | Breast Feeding
    Item
    3. participants who are pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Informed Consent Unable | Informed Consent Unwilling | Legal Guardian Informed Consent Unable | Legal Guardian Informed Consent Unwilling
    Item
    4. inability or unwillingness of research participant or legal guardian to consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2,1])
    C0558080 (UMLS CUI [2,2])
    C0023226 (UMLS CUI [3,1])
    C0021430 (UMLS CUI [3,2])
    C1299582 (UMLS CUI [3,3])
    C0023226 (UMLS CUI [4,1])
    C0021430 (UMLS CUI [4,2])
    C0558080 (UMLS CUI [4,3])
    Emergency Steroids | Emergency Therapeutic radiology procedure | Study biological Excluded
    Item
    5. participants who received emergent steroids and/or radiation prior to biopsy may be included in therapeutic part of study, but will be excluded from biology studies.
    boolean
    C0013956 (UMLS CUI [1,1])
    C0038317 (UMLS CUI [1,2])
    C0013956 (UMLS CUI [2,1])
    C1522449 (UMLS CUI [2,2])
    C2603343 (UMLS CUI [3,1])
    C0205460 (UMLS CUI [3,2])
    C0332196 (UMLS CUI [3,3])
    Collaboration Study Site | Objective biological
    Item
    participants from collaborating sites participating in biological objectives only:
    boolean
    C0282116 (UMLS CUI [1,1])
    C2825164 (UMLS CUI [1,2])
    C0018017 (UMLS CUI [2,1])
    C0205460 (UMLS CUI [2,2])
    Informed Consent Unable | Informed Consent Unwilling | Legal Guardian Informed Consent Unable | Legal Guardian Informed Consent Unwilling
    Item
    1. inability or unwillingness of research participant or legal guardian to consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2,1])
    C0558080 (UMLS CUI [2,2])
    C0023226 (UMLS CUI [3,1])
    C0021430 (UMLS CUI [3,2])
    C1299582 (UMLS CUI [3,3])
    C0023226 (UMLS CUI [4,1])
    C0021430 (UMLS CUI [4,2])
    C0558080 (UMLS CUI [4,3])
    Histological diagnosis WHO classification | Exception Mature B-Cell Lymphoma
    Item
    2. histologic diagnosis other than a mature b-cell lymphoma as defined in the who classification
    boolean
    C0679557 (UMLS CUI [1,1])
    C4267671 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C1334634 (UMLS CUI [2,2])
    Emergency Steroids | Emergency Therapeutic radiology procedure
    Item
    3. participants who received emergent steroids and/or radiation prior to biopsy
    boolean
    C0013956 (UMLS CUI [1,1])
    C0038317 (UMLS CUI [1,2])
    C0013956 (UMLS CUI [2,1])
    C1522449 (UMLS CUI [2,2])
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