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ID

35837

Beskrivning

The Palliative Benefit of Involved-site Radiotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02449278

Länk

https://clinicaltrials.gov/show/NCT02449278

Nyckelord

Versioner (1)
  1. 2019-03-26 2019-03-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 mars 2019

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Creative Commons BY 4.0
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    Eligibility Diffuse Large B-cell Lymphoma NCT02449278

    Engelsk

    Eligibility Diffuse Large B-cell Lymphoma NCT02449278

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    both male and female aged range from 18 years to 65 years.
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    eastern cooperative oncology group(ecog) performance status of 0 or 1.
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    all patients had histologically confirmed diffuse large b-cell lymphoma.
    Beskrivning

    Diffuse Large B-Cell Lymphoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0079744 (Diffuse Large B-Cell Lymphoma)
    SNOMED
    109969005
    advanced-stage dlbcl patients at newly diagnosed or recurrent without rt in initial management.
    Beskrivning

    Diffuse Large B-Cell Lymphoma Stage Advanced | Diffuse large B-cell lymphoma recurrent | Therapeutic radiology procedure Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744 (Diffuse Large B-Cell Lymphoma)
    SNOMED
    109969005
    UMLS CUI [1,2]
    C1306673 (Stage)
    SNOMED
    258214002
    LOINC
    LP73395-3
    UMLS CUI [1,3]
    C0205179 (Advanced phase)
    SNOMED
    86005002
    UMLS CUI [2]
    C0855111 (Diffuse large B-cell lymphoma recurrent)
    UMLS CUI [3,1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [3,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    adequate organ function.
    Beskrivning

    Organ function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0678852 (body system or organ function)
    negative pregnancy test.
    Beskrivning

    Pregnancy test negative

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0427780 (Pregnancy test negative)
    SNOMED
    250425007
    signed informed consent document on file.
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    woman who were pregnant or lactating.
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    with severe local infection or general infective disease.
    Beskrivning

    Local infection Severe | Communicable Disease General

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1400591 (local; infection)
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [2,1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [2,2]
    C0205246 (Generalized)
    SNOMED
    60132005
    LOINC
    LA18721-3
    primary lymphoma in special organ including cuticula, center never system, gastrointestinal tract, testicle, and lung.
    Beskrivning

    Lymphoma Primary Organ Special | Cuticle | Central Nervous System | Gastrointestinal tract | Testis | Lung

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    UMLS CUI [1,2]
    C0205225 (Primary)
    SNOMED
    63161005
    LOINC
    LA21208-6
    UMLS CUI [1,3]
    C0178784 (Organ)
    UMLS CUI [1,4]
    C0205555 (Special)
    SNOMED
    67995009
    UMLS CUI [2]
    C2699479 (Cuticle)
    UMLS CUI [3]
    C3714787 (Central Nervous System)
    SNOMED
    21483005
    LOINC
    LA4174-4
    UMLS CUI [4]
    C0017189 (Gastrointestinal tract structure)
    SNOMED
    51289009
    UMLS CUI [5]
    C0039597 (Testis)
    SNOMED
    40689003
    LOINC
    LP36008-8
    UMLS CUI [6]
    C0024109 (Lung)
    SNOMED
    39607008
    LOINC
    LP7407-2
    with other second primary malignancy except cutaneum carcinoma.
    Beskrivning

    Second Primary Cancer | Exception Skin carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0751623 (Second Primary Cancers)
    SNOMED
    878806005
    UMLS CUI [2,1]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [2,2]
    C0699893 (Skin carcinoma)
    being or planning to participate in other study.
    Beskrivning

    Study Subject Participation Status | Study Subject Participation Status Planned

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2,2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    any patient who in the opinion of the investigator should not participate in the study.
    Beskrivning

    Study Subject Participation Status Ineligible

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C1512714 (Ineligibility)
    withdrawal criteria:
    Beskrivning

    Withdrawal criteria

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677 (Withdrawal by Subject)
    UMLS CUI [1,2]
    C0243161 (criteria)
    patient are free to withdrawal completely from the study at any time upon request.
    Beskrivning

    Withdrawal Patient Decision

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677 (Withdrawal by Subject)
    UMLS CUI [1,2]
    C4527299 (Patient Decision)
    patient in the study may be stopped with the patient agreement at any time at the discretion of investigator.
    Beskrivning

    Study Subject Participation Status Stopped

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C1272691 (To be stopped)
    SNOMED
    385654001
    in-field progression on irradiation ongoing.
    Beskrivning

    Radiation Field Disease Progression | Therapeutic radiology procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1882536 (Radiation Field)
    UMLS CUI [1,2]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    UMLS CUI [2]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    poor tolerability adverse events in the period of chemotherapy or irradiation after enrolled in the study.
    Beskrivning

    Adverse event Chemotherapy | Adverse event Therapeutic radiology procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [2,2]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    Tillbaka till toppen

    Similar models

    Eligibility Diffuse Large B-cell Lymphoma NCT02449278

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    both male and female aged range from 18 years to 65 years.
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    eastern cooperative oncology group(ecog) performance status of 0 or 1.
    boolean
    C1520224 (UMLS CUI [1])
    Diffuse Large B-Cell Lymphoma
    Item
    all patients had histologically confirmed diffuse large b-cell lymphoma.
    boolean
    C0079744 (UMLS CUI [1])
    Diffuse Large B-Cell Lymphoma Stage Advanced | Diffuse large B-cell lymphoma recurrent | Therapeutic radiology procedure Absent
    Item
    advanced-stage dlbcl patients at newly diagnosed or recurrent without rt in initial management.
    boolean
    C0079744 (UMLS CUI [1,1])
    C1306673 (UMLS CUI [1,2])
    C0205179 (UMLS CUI [1,3])
    C0855111 (UMLS CUI [2])
    C1522449 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Organ function
    Item
    adequate organ function.
    boolean
    C0678852 (UMLS CUI [1])
    Pregnancy test negative
    Item
    negative pregnancy test.
    boolean
    C0427780 (UMLS CUI [1])
    Informed Consent
    Item
    signed informed consent document on file.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy | Breast Feeding
    Item
    woman who were pregnant or lactating.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Local infection Severe | Communicable Disease General
    Item
    with severe local infection or general infective disease.
    boolean
    C1400591 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0009450 (UMLS CUI [2,1])
    C0205246 (UMLS CUI [2,2])
    Lymphoma Primary Organ Special | Cuticle | Central Nervous System | Gastrointestinal tract | Testis | Lung
    Item
    primary lymphoma in special organ including cuticula, center never system, gastrointestinal tract, testicle, and lung.
    boolean
    C0024299 (UMLS CUI [1,1])
    C0205225 (UMLS CUI [1,2])
    C0178784 (UMLS CUI [1,3])
    C0205555 (UMLS CUI [1,4])
    C2699479 (UMLS CUI [2])
    C3714787 (UMLS CUI [3])
    C0017189 (UMLS CUI [4])
    C0039597 (UMLS CUI [5])
    C0024109 (UMLS CUI [6])
    Second Primary Cancer | Exception Skin carcinoma
    Item
    with other second primary malignancy except cutaneum carcinoma.
    boolean
    C0751623 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0699893 (UMLS CUI [2,2])
    Study Subject Participation Status | Study Subject Participation Status Planned
    Item
    being or planning to participate in other study.
    boolean
    C2348568 (UMLS CUI [1])
    C2348568 (UMLS CUI [2,1])
    C1301732 (UMLS CUI [2,2])
    Study Subject Participation Status Ineligible
    Item
    any patient who in the opinion of the investigator should not participate in the study.
    boolean
    C2348568 (UMLS CUI [1,1])
    C1512714 (UMLS CUI [1,2])
    Withdrawal criteria
    Item
    withdrawal criteria:
    boolean
    C1710677 (UMLS CUI [1,1])
    C0243161 (UMLS CUI [1,2])
    Withdrawal Patient Decision
    Item
    patient are free to withdrawal completely from the study at any time upon request.
    boolean
    C1710677 (UMLS CUI [1,1])
    C4527299 (UMLS CUI [1,2])
    Study Subject Participation Status Stopped
    Item
    patient in the study may be stopped with the patient agreement at any time at the discretion of investigator.
    boolean
    C2348568 (UMLS CUI [1,1])
    C1272691 (UMLS CUI [1,2])
    Radiation Field Disease Progression | Therapeutic radiology procedure
    Item
    in-field progression on irradiation ongoing.
    boolean
    C1882536 (UMLS CUI [1,1])
    C0242656 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2])
    Adverse event Chemotherapy | Adverse event Therapeutic radiology procedure
    Item
    poor tolerability adverse events in the period of chemotherapy or irradiation after enrolled in the study.
    boolean
    C0877248 (UMLS CUI [1,1])
    C0392920 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [2,1])
    C1522449 (UMLS CUI [2,2])
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