ID

35837

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02449278

Palabras clave

Versiones (1)
  1. 26/3/19 26/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

26 de marzo de 2019

DOI

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Licencia

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

    Inglés

    Eligibility Diffuse Large B-cell Lymphoma NCT02449278

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    both male and female aged range from 18 years to 65 years.
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    eastern cooperative oncology group(ecog) performance status of 0 or 1.
    Descripción

    ECOG performance status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    all patients had histologically confirmed diffuse large b-cell lymphoma.
    Descripción

    Diffuse Large B-Cell Lymphoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0079744
    advanced-stage dlbcl patients at newly diagnosed or recurrent without rt in initial management.
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744
    UMLS CUI [1,2]
    C1306673
    UMLS CUI [1,3]
    C0205179
    UMLS CUI [2]
    C0855111
    UMLS CUI [3,1]
    C1522449
    UMLS CUI [3,2]
    C0332197
    adequate organ function.
    Descripción

    Organ function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    negative pregnancy test.
    Descripción

    Pregnancy test negative

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0427780
    signed informed consent document on file.
    Descripción

    Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    woman who were pregnant or lactating.
    Descripción

    Pregnancy | Breast Feeding

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    with severe local infection or general infective disease.
    Descripción

    Local infection Severe | Communicable Disease General

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1400591
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0009450
    UMLS CUI [2,2]
    C0205246
    primary lymphoma in special organ including cuticula, center never system, gastrointestinal tract, testicle, and lung.
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0024299
    UMLS CUI [1,2]
    C0205225
    UMLS CUI [1,3]
    C0178784
    UMLS CUI [1,4]
    C0205555
    UMLS CUI [2]
    C2699479
    UMLS CUI [3]
    C3714787
    UMLS CUI [4]
    C0017189
    UMLS CUI [5]
    C0039597
    UMLS CUI [6]
    C0024109
    with other second primary malignancy except cutaneum carcinoma.
    Descripción

    Second Primary Cancer | Exception Skin carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0751623
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0699893
    being or planning to participate in other study.
    Descripción

    Study Subject Participation Status | Study Subject Participation Status Planned

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2,1]
    C2348568
    UMLS CUI [2,2]
    C1301732
    any patient who in the opinion of the investigator should not participate in the study.
    Descripción

    Study Subject Participation Status Ineligible

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C1512714
    withdrawal criteria:
    Descripción

    Withdrawal criteria

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677
    UMLS CUI [1,2]
    C0243161
    patient are free to withdrawal completely from the study at any time upon request.
    Descripción

    Withdrawal Patient Decision

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677
    UMLS CUI [1,2]
    C4527299
    patient in the study may be stopped with the patient agreement at any time at the discretion of investigator.
    Descripción

    Study Subject Participation Status Stopped

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C1272691
    in-field progression on irradiation ongoing.
    Descripción

    Radiation Field Disease Progression | Therapeutic radiology procedure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1882536
    UMLS CUI [1,2]
    C0242656
    UMLS CUI [2]
    C1522449
    poor tolerability adverse events in the period of chemotherapy or irradiation after enrolled in the study.
    Descripción

    Adverse event Chemotherapy | Adverse event Therapeutic radiology procedure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0392920
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C1522449
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    Similar models

    Eligibility Diffuse Large B-cell Lymphoma NCT02449278

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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