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ID

15865

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02344667

Trefwoorden

  1. 17-06-16 17-06-16 -
Geüploaded op

17 juni 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Prostatic Neoplasms NCT02344667

    Eligibility Prostatic Neoplasms NCT02344667

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    histologically confirmed diagnosis of adenocarcinoma of the prostate
    Beschrijving

    Adenocarcinoma of prostate

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0007112 (Adenocarcinoma of prostate)
    SNOMED
    399490008
    histological evaluation of prostate biopsy with assignment of a gleason score to the biopsy material; gleason scores ≤ 7
    Beschrijving

    Biopsy of prostate | Evaluation Histologic | Gleason score

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0194804 (Biopsy of prostate)
    SNOMED
    65575008
    UMLS CUI [2,1]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    UMLS CUI [2,2]
    C0205462 (Histologic)
    SNOMED
    67151002
    UMLS CUI [3]
    C3203027 (Gleason score)
    SNOMED
    372278000
    LOINC
    LP33134-5
    clinical stage t1-2b (ajcc 7th edition)
    Beschrijving

    TNM clinical staging

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3258246 (TNM clinical staging)
    LOINC
    LP130437-9
    psa ≤ 10 ng/ml. psa should not be obtained within 10 days after prostate biopsy.
    Beschrijving

    Prostate specific antigen measurement | Biopsy of prostate

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0201544 (Prostate specific antigen measurement)
    SNOMED
    63476009
    UMLS CUI [2]
    C0194804 (Biopsy of prostate)
    SNOMED
    65575008
    ecog performance status 0-1
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

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

    invasive cancer | Skin carcinoma | Lymphoma | Malignant Neoplasms hematogenous

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0677898 (Invasive Malignant Neoplasm)
    UMLS CUI [2]
    C0699893 (Skin carcinoma)
    UMLS CUI [3]
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    UMLS CUI [4,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [4,2]
    C1512376 (Hematogenous)
    evidence of distant metastases
    Beschrijving

    distant metastases

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3258247 (TNM clinical staging - distant metastases - M)
    LOINC
    LP130440-3
    regional lymph node involvement
    Beschrijving

    Lymph Node Involvement regional

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0806692 (Lymph Node Involvement)
    UMLS CUI [1,2]
    C0205147 (regional)
    SNOMED
    410673009
    LOINC
    LP73261-7
    previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer. previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0455610 (H/O: surgery)
    SNOMED
    161615003
    UMLS CUI [1,2]
    C0439807 (Radical (qualifier value))
    SNOMED
    255612005
    UMLS CUI [2]
    C0033573 (Prostatectomy)
    SNOMED
    90470006
    LOINC
    LA25558-0
    UMLS CUI [3]
    C0010408 (Cryosurgery)
    SNOMED
    427357007
    LOINC
    LP263435-2
    UMLS CUI [4,1]
    C0441583 (High intensity focused ultrasound)
    SNOMED
    257859002
    UMLS CUI [4,2]
    C0600139 (Prostate carcinoma)
    SNOMED
    254900004
    UMLS CUI [5,1]
    C0030797 (Pelvis)
    SNOMED
    12921003
    LOINC
    LP7467-6
    UMLS CUI [5,2]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [5,3]
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    UMLS CUI [6]
    C0854662 (Brachytherapy to prostate)
    UMLS CUI [7]
    C0007347 (Male Castration)
    SNOMED
    386634006
    previous hormonal therapy, such as lhrh agonists or lhrh antagonists, anti-androgens, estrogens, or surgical castration
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1514460 (Prior Hormone Therapy)
    UMLS CUI [2]
    C1518041 (Luteinizing Hormone-releasing Hormone Agonist)
    UMLS CUI [3]
    C1276926 (Luteinizing hormone releasing hormone antagonist product)
    UMLS CUI [4]
    C0002842 (Androgen Antagonists)
    SNOMED
    103024009
    UMLS CUI [5]
    C0014939 (estrogens)
    SNOMED
    61946003
    UMLS CUI [6]
    C0007344 (Castration)
    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.
    Beschrijving

    Finasteride Use | Dutasteride Use | Prostate-Specific Antigen

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0060389 (finasteride)
    SNOMED
    109035006
    UMLS CUI [1,2]
    C1524063 (Use of)
    SNOMED
    260676000
    UMLS CUI [2,1]
    C0754659 (dutasteride)
    SNOMED
    385570006
    UMLS CUI [2,2]
    C1524063 (Use of)
    SNOMED
    260676000
    UMLS CUI [3]
    C0138741 (Prostate-Specific Antigen)
    SNOMED
    102687007
    LOINC
    LP18193-0
    previous or concurrent cytotoxic chemotherapy for prostate cancer
    Beschrijving

    Cytotoxic Chemotherapy Prostate carcinoma

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0677881 (Cytotoxic Chemotherapy)
    UMLS CUI [1,2]
    C0600139 (Prostate carcinoma)
    SNOMED
    254900004
    age < 18
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    patient unable to provide study-specific informed consent
    Beschrijving

    Informed Consent Unable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7
    inability to complete the expanded prostate cancer index composite (epic) questionnaire
    Beschrijving

    Expanded Prostate Cancer Index Composite Questionnaire | Completion Unable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3810535 (Expanded Prostate Cancer Index Composite)
    UMLS CUI [1,2]
    C0034394 (Questionnaires)
    UMLS CUI [2,1]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    UMLS CUI [2,2]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7

    Similar models

    Eligibility Prostatic Neoplasms NCT02344667

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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