0 Beoordelingen
ID

22710

Beschrijving

Prospective Randomized Trial of Seminal Vesicle-Sparing Prostatectomy and Nerve-Sparing Radical Prostatectomy in Men With Clinically Localized Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01825642

Link

https://clinicaltrials.gov/show/NCT01825642

Trefwoorden

Versies (1)
  1. 10-06-17 10-06-17 -
Geüploaded op

10 juni 2017

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Prostate Cancer NCT01825642

    Engels

    Eligibility Prostate Cancer NCT01825642

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    men with biopsy-proven histologic diagnosis of prostate adenocarcinoma
    Beschrijving

    gender, histologically confirmed adenocarcinoma of the prostate

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2,1]
    C0679557 (histological diagnosis)
    UMLS CUI [2,2]
    C0007112 (Adenocarcinoma of prostate)
    SNOMED
    399490008
    low risk for seminal vesicle invasions defined by:
    Beschrijving

    low risk for seminal vesicle invasions

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3538919 (Low risk (qualifier value))
    SNOMED
    723505004
    UMLS CUI [1,2]
    C1718327 (Seminal vesicle invasion)
    LOINC
    MTHU020034
    clinical stage t1c/tumor 2-node 0-metastasis 0, gleason score ≤ 6, psa ≤ 10 ng/ml, positive prostate biopsy core proportion ≤ 1/2 (50%) or clinical stage t1c/t2n0m0, gleason ≤ 7, psa ≤ 6 ng/ml, positive biopsy core proportion ≤ 1/3 (33.3%)
    Beschrijving

    clinical TNM stage, gleason, psa, positive prostate biopsy core proportion

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1707417 (Clinical TNM Finding)
    UMLS CUI [2]
    C3203027 (Gleason score)
    SNOMED
    372278000
    LOINC
    LP33134-5
    UMLS CUI [3]
    C0201544 (Prostate specific antigen measurement)
    SNOMED
    63476009
    UMLS CUI [4,1]
    C0194804 (Biopsy of prostate)
    SNOMED
    65575008
    UMLS CUI [4,2]
    C1446409 (Positive)
    SNOMED
    10828004
    UMLS CUI [4,3]
    C0444669 (Core)
    SNOMED
    260235002
    LOINC
    LP7152-4
    UMLS CUI [4,4]
    C1709707 (Proportion)
    sexually potent, defined as international index of erectile function score ≥ 21, prior to randomization and surgery
    Beschrijving

    international index of erectile function score

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2959364 (International index of erectile function score)
    SNOMED
    445930007
    competent to provide informed consent
    Beschrijving

    informed consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    able to read and write english
    Beschrijving

    english

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0376245 (English Language)
    SNOMED
    297487008
    LOINC
    LA43-5
    candidate for bilateral nerve-sparing
    Beschrijving

    bilateral nerve-sparing

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0444743 (Bilateral nerve sparing attempt)
    willing to be followed for 12 months post-surgery
    Beschrijving

    compliance follow-up

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C1522577 (follow-up)
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    intermediate or high risk for seminal vesicle invasion
    Beschrijving

    intermediate or high risk for seminal vesicle invasion

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3640764 (Intermediate Risk)
    UMLS CUI [1,2]
    C0332167 (High risk of)
    SNOMED
    15508007
    UMLS CUI [1,3]
    C1718327 (Seminal vesicle invasion)
    LOINC
    MTHU020034
    unwilling to be randomized to either treatment arm
    Beschrijving

    unwilling to be randomized

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0558080 (Unwilling)
    SNOMED
    225465005
    UMLS CUI [1,2]
    C0034656 (Randomization)
    pre-operative treatment with radiation and/or hormone therapy
    Beschrijving

    pre-operative treatment with radiation and/or hormone therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0279134 (Prior Radiation Therapy)
    UMLS CUI [2]
    C1514460 (Prior Hormone Therapy)
    planned adjuvant radiation and/or hormonal therapy
    Beschrijving

    planned adjuvant radiation and/or hormonal therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    UMLS CUI [1,2]
    C1706721 (Adjuvant Radiation Therapy)
    UMLS CUI [2,1]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    UMLS CUI [2,2]
    C1971498 (Adjuvant (ie, in combination with external beam radiotherapy to the prostate for prostate cancer) hormonal therapy (gonadotropin-releasing hormone [GnRH] agonist or antagonist) prescribed/administered (PRCA))
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    Similar models

    Eligibility Prostate Cancer NCT01825642

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    gender, histologically confirmed adenocarcinoma of the prostate
    Item
    men with biopsy-proven histologic diagnosis of prostate adenocarcinoma
    boolean
    C0079399 (UMLS CUI [1])
    C0679557 (UMLS CUI [2,1])
    C0007112 (UMLS CUI [2,2])
    low risk for seminal vesicle invasions
    Item
    low risk for seminal vesicle invasions defined by:
    boolean
    C3538919 (UMLS CUI [1,1])
    C1718327 (UMLS CUI [1,2])
    clinical TNM stage, gleason, psa, positive prostate biopsy core proportion
    Item
    clinical stage t1c/tumor 2-node 0-metastasis 0, gleason score ≤ 6, psa ≤ 10 ng/ml, positive prostate biopsy core proportion ≤ 1/2 (50%) or clinical stage t1c/t2n0m0, gleason ≤ 7, psa ≤ 6 ng/ml, positive biopsy core proportion ≤ 1/3 (33.3%)
    boolean
    C1707417 (UMLS CUI [1])
    C3203027 (UMLS CUI [2])
    C0201544 (UMLS CUI [3])
    C0194804 (UMLS CUI [4,1])
    C1446409 (UMLS CUI [4,2])
    C0444669 (UMLS CUI [4,3])
    C1709707 (UMLS CUI [4,4])
    international index of erectile function score
    Item
    sexually potent, defined as international index of erectile function score ≥ 21, prior to randomization and surgery
    boolean
    C2959364 (UMLS CUI [1])
    informed consent
    Item
    competent to provide informed consent
    boolean
    C0021430 (UMLS CUI [1])
    english
    Item
    able to read and write english
    boolean
    C0376245 (UMLS CUI [1])
    bilateral nerve-sparing
    Item
    candidate for bilateral nerve-sparing
    boolean
    C0444743 (UMLS CUI [1])
    compliance follow-up
    Item
    willing to be followed for 12 months post-surgery
    boolean
    C1321605 (UMLS CUI [1,1])
    C1522577 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    intermediate or high risk for seminal vesicle invasion
    Item
    intermediate or high risk for seminal vesicle invasion
    boolean
    C3640764 (UMLS CUI [1,1])
    C0332167 (UMLS CUI [1,2])
    C1718327 (UMLS CUI [1,3])
    unwilling to be randomized
    Item
    unwilling to be randomized to either treatment arm
    boolean
    C0558080 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    pre-operative treatment with radiation and/or hormone therapy
    Item
    pre-operative treatment with radiation and/or hormone therapy
    boolean
    C0279134 (UMLS CUI [1])
    C1514460 (UMLS CUI [2])
    planned adjuvant radiation and/or hormonal therapy
    Item
    planned adjuvant radiation and/or hormonal therapy
    boolean
    C1301732 (UMLS CUI [1,1])
    C1706721 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [2,1])
    C1971498 (UMLS CUI [2,2])
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