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ID

15865

Beskrivning

Feasibility Study of Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer: Cyberknife vs. VMAT; ODM derived from: https://clinicaltrials.gov/show/NCT02344667

Länk

https://clinicaltrials.gov/show/NCT02344667

Nyckelord

  1. 2016-06-17 2016-06-17 -
Uppladdad den

17 juni 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Prostatic Neoplasms NCT02344667

    Eligibility Prostatic Neoplasms NCT02344667

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically confirmed diagnosis of adenocarcinoma of the prostate
    Beskrivning

    Adenocarcinoma of prostate

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0007112
    histological evaluation of prostate biopsy with assignment of a gleason score to the biopsy material; gleason scores ≤ 7
    Beskrivning

    Biopsy of prostate | Evaluation Histologic | Gleason score

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0194804
    UMLS CUI [2,1]
    C0220825
    UMLS CUI [2,2]
    C0205462
    UMLS CUI [3]
    C3203027
    clinical stage t1-2b (ajcc 7th edition)
    Beskrivning

    TNM clinical staging

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3258246
    psa ≤ 10 ng/ml. psa should not be obtained within 10 days after prostate biopsy.
    Beskrivning

    Prostate specific antigen measurement | Biopsy of prostate

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201544
    UMLS CUI [2]
    C0194804
    ecog performance status 0-1
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
    Beskrivning

    invasive cancer | Skin carcinoma | Lymphoma | Malignant Neoplasms hematogenous

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0677898
    UMLS CUI [2]
    C0699893
    UMLS CUI [3]
    C0024299
    UMLS CUI [4,1]
    C0006826
    UMLS CUI [4,2]
    C1512376
    evidence of distant metastases
    Beskrivning

    distant metastases

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3258247
    regional lymph node involvement
    Beskrivning

    Lymph Node Involvement regional

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0806692
    UMLS CUI [1,2]
    C0205147
    previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer. previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
    Beskrivning

    H/O: surgery Radical | Prostatectomy | Cryosurgery | High intensity focused ultrasound Prostate carcinoma | Pelvis Therapeutic radiology procedure Previous | Brachytherapy to prostate | Male Castration

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0455610
    UMLS CUI [1,2]
    C0439807
    UMLS CUI [2]
    C0033573
    UMLS CUI [3]
    C0010408
    UMLS CUI [4,1]
    C0441583
    UMLS CUI [4,2]
    C0600139
    UMLS CUI [5,1]
    C0030797
    UMLS CUI [5,2]
    C1522449
    UMLS CUI [5,3]
    C0205156
    UMLS CUI [6]
    C0854662
    UMLS CUI [7]
    C0007347
    previous hormonal therapy, such as lhrh agonists or lhrh antagonists, anti-androgens, estrogens, or surgical castration
    Beskrivning

    Prior Hormone Therapy | LHRH Agonist | LHRH antagonist | Androgen Antagonists | Estrogens | Castration

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1514460
    UMLS CUI [2]
    C1518041
    UMLS CUI [3]
    C1276926
    UMLS CUI [4]
    C0002842
    UMLS CUI [5]
    C0014939
    UMLS CUI [6]
    C0007344
    use of finasteride or dutasteride within 30 days prior to registration. psa should not be obtained prior to 30 days after stopping finasteride or dutasteride.
    Beskrivning

    Finasteride Use | Dutasteride Use | Prostate-Specific Antigen

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0060389
    UMLS CUI [1,2]
    C1524063
    UMLS CUI [2,1]
    C0754659
    UMLS CUI [2,2]
    C1524063
    UMLS CUI [3]
    C0138741
    previous or concurrent cytotoxic chemotherapy for prostate cancer
    Beskrivning

    Cytotoxic Chemotherapy Prostate carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0677881
    UMLS CUI [1,2]
    C0600139
    age < 18
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patient unable to provide study-specific informed consent
    Beskrivning

    Informed Consent Unable

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582
    inability to complete the expanded prostate cancer index composite (epic) questionnaire
    Beskrivning

    Expanded Prostate Cancer Index Composite Questionnaire | Completion Unable

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3810535
    UMLS CUI [1,2]
    C0034394
    UMLS CUI [2,1]
    C0205197
    UMLS CUI [2,2]
    C1299582

    Similar models

    Eligibility Prostatic Neoplasms NCT02344667

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adenocarcinoma of prostate
    Item
    histologically confirmed diagnosis of adenocarcinoma of the prostate
    boolean
    C0007112 (UMLS CUI [1])
    Biopsy of prostate | Evaluation Histologic | Gleason score
    Item
    histological evaluation of prostate biopsy with assignment of a gleason score to the biopsy material; gleason scores ≤ 7
    boolean
    C0194804 (UMLS CUI [1])
    C0220825 (UMLS CUI [2,1])
    C0205462 (UMLS CUI [2,2])
    C3203027 (UMLS CUI [3])
    TNM clinical staging
    Item
    clinical stage t1-2b (ajcc 7th edition)
    boolean
    C3258246 (UMLS CUI [1])
    Prostate specific antigen measurement | Biopsy of prostate
    Item
    psa ≤ 10 ng/ml. psa should not be obtained within 10 days after prostate biopsy.
    boolean
    C0201544 (UMLS CUI [1])
    C0194804 (UMLS CUI [2])
    ECOG performance status
    Item
    ecog performance status 0-1
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    invasive cancer | Skin carcinoma | Lymphoma | Malignant Neoplasms hematogenous
    Item
    prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
    boolean
    C0677898 (UMLS CUI [1])
    C0699893 (UMLS CUI [2])
    C0024299 (UMLS CUI [3])
    C0006826 (UMLS CUI [4,1])
    C1512376 (UMLS CUI [4,2])
    distant metastases
    Item
    evidence of distant metastases
    boolean
    C3258247 (UMLS CUI [1])
    Lymph Node Involvement regional
    Item
    regional lymph node involvement
    boolean
    C0806692 (UMLS CUI [1,1])
    C0205147 (UMLS CUI [1,2])
    H/O: surgery Radical | Prostatectomy | Cryosurgery | High intensity focused ultrasound Prostate carcinoma | Pelvis Therapeutic radiology procedure Previous | Brachytherapy to prostate | Male Castration
    Item
    previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer. previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
    boolean
    C0455610 (UMLS CUI [1,1])
    C0439807 (UMLS CUI [1,2])
    C0033573 (UMLS CUI [2])
    C0010408 (UMLS CUI [3])
    C0441583 (UMLS CUI [4,1])
    C0600139 (UMLS CUI [4,2])
    C0030797 (UMLS CUI [5,1])
    C1522449 (UMLS CUI [5,2])
    C0205156 (UMLS CUI [5,3])
    C0854662 (UMLS CUI [6])
    C0007347 (UMLS CUI [7])
    Prior Hormone Therapy | LHRH Agonist | LHRH antagonist | Androgen Antagonists | Estrogens | Castration
    Item
    previous hormonal therapy, such as lhrh agonists or lhrh antagonists, anti-androgens, estrogens, or surgical castration
    boolean
    C1514460 (UMLS CUI [1])
    C1518041 (UMLS CUI [2])
    C1276926 (UMLS CUI [3])
    C0002842 (UMLS CUI [4])
    C0014939 (UMLS CUI [5])
    C0007344 (UMLS CUI [6])
    Finasteride Use | Dutasteride Use | Prostate-Specific Antigen
    Item
    use of finasteride or dutasteride within 30 days prior to registration. psa should not be obtained prior to 30 days after stopping finasteride or dutasteride.
    boolean
    C0060389 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    C0754659 (UMLS CUI [2,1])
    C1524063 (UMLS CUI [2,2])
    C0138741 (UMLS CUI [3])
    Cytotoxic Chemotherapy Prostate carcinoma
    Item
    previous or concurrent cytotoxic chemotherapy for prostate cancer
    boolean
    C0677881 (UMLS CUI [1,1])
    C0600139 (UMLS CUI [1,2])
    Age
    Item
    age < 18
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent Unable
    Item
    patient unable to provide study-specific informed consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Expanded Prostate Cancer Index Composite Questionnaire | Completion Unable
    Item
    inability to complete the expanded prostate cancer index composite (epic) questionnaire
    boolean
    C3810535 (UMLS CUI [1,1])
    C0034394 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [2,1])
    C1299582 (UMLS CUI [2,2])

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