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

Uploaded on

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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Similar models

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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