0 Evaluaciones

ID

13874

Descripción

Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01446991

Link

https://clinicaltrials.gov/show/NCT01446991

Palabras clave

  1. 13/3/16 13/3/16 -
Subido en

13 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0

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    Eligibility Prostate Cancer NCT01446991

    Eligibility Prostate Cancer NCT01446991

    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    histologic diagnosis of prostate cancer
    Descripción

    prostate cancer

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0600139 (Prostate carcinoma)
    SNOMED
    254900004
    favorable risk disease (ct1 or t2a, gleason score (gs) 6, and prostate specific antigen (psa) < 10 ng/ml)
    Descripción

    tumor stage; gleason score; prostate specific antigen

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1300072 (Tumor stage)
    SNOMED
    371508000
    UMLS CUI [2]
    C3203027 (Gleason score)
    SNOMED
    372278000
    LOINC
    LP33134-5
    UMLS CUI [3]
    C0138741 (Prostate-Specific Antigen)
    SNOMED
    102687007
    LOINC
    LP18193-0
    low-tier intermediate risk disease (ct2c,gs=6,and psa 10-15 ng/ml, or gs=7 and psa < 10 ng/ml)
    Descripción

    tumor stage; gleason score; prostate specific antigen

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1300072 (Tumor stage)
    SNOMED
    371508000
    UMLS CUI [2]
    C3203027 (Gleason score)
    SNOMED
    372278000
    LOINC
    LP33134-5
    UMLS CUI [3]
    C0138741 (Prostate-Specific Antigen)
    SNOMED
    102687007
    LOINC
    LP18193-0
    intermediate risk disease and androgen deprivation therapy recommended by the treating physician for oncologic reasons such as (≥ 50% positive biopsy cores,ct2c,psa 15-20 ng/ml,gs=7)
    Descripción

    Antiandrogen therapy; positive biopsy cores; tumor stage; gleason score; prostate specific antigen

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0279492 (Antiandrogen therapy)
    SNOMED
    707266006
    UMLS CUI [2]
    C1276779 (Number of cores positive / total number of cores)
    SNOMED
    372280006
    UMLS CUI [3]
    C1300072 (Tumor stage)
    SNOMED
    371508000
    UMLS CUI [4]
    C3203027 (Gleason score)
    SNOMED
    372278000
    LOINC
    LP33134-5
    UMLS CUI [5]
    C0138741 (Prostate-Specific Antigen)
    SNOMED
    102687007
    LOINC
    LP18193-0
    patient requires baseline planning trans-rectal ultrasound for the purposes of prostate brachytherapy, showing prostate volume > 40 ml and pubic arch interference (not required for those requiring androgen ablation for oncologic reasons)
    Descripción

    trans-rectal ultrasound prostate volume for prostate brachytherapy; androgen ablation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0812546 (Ultrasound, transrectal; prostate volume study for brachytherapy treatment planning (separate procedure))
    UMLS CUI [2]
    C1515985 (Androgen Suppression)
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    castrate serum testosterone level
    Descripción

    serum testosterone

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0428413 (Serum testosterone measurement)
    SNOMED
    270973006
    previous or concurrent pelvic radiotherapy
    Descripción

    pelvic radiotherapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0436276 (Radiotherapy: temporary pelvic implant)
    SNOMED
    169370006
    unable to give written informed consent
    Descripción

    informed consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    contraindications to permanent seed prostate brachytherapy or to androgen deprivation therapy
    Descripción

    prostate brachytherapy; Antiandrogen therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0854662 (Brachytherapy to prostate)
    UMLS CUI [2]
    C0279492 (Antiandrogen therapy)
    SNOMED
    707266006
    prior treatment for prostate cancer
    Descripción

    Study Subject Participation Status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    prior trans-urethral resection of the prostate
    Descripción

    Transurethral Resection of Prostate

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0040771 (Transurethral Resection of Prostate)
    SNOMED
    90199006
    previous therapy with a 5-α reductase inhibitor, anti-androgen agent, or lhrh agonist
    Descripción

    therapy 5-alpha Reductase Inhibitors Androgen Antagonists; Luteinizing Hormone-releasing Hormone Agonist

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C2936788 (5-alpha Reductase Inhibitors)
    SNOMED
    406757009
    UMLS CUI [1,3]
    C0002842 (Androgen Antagonists)
    SNOMED
    103024009
    UMLS CUI [1,4]
    C1518041 (Luteinizing Hormone-releasing Hormone Agonist)
    previous therapy with degarelix
    Descripción

    therapy degarelix

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C1455035 (degarelix)
    SNOMED
    441864003

    Similar models

    Eligibility Prostate Cancer NCT01446991

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    prostate cancer
    Item
    histologic diagnosis of prostate cancer
    boolean
    C0600139 (UMLS CUI [1])
    tumor stage; gleason score; prostate specific antigen
    Item
    favorable risk disease (ct1 or t2a, gleason score (gs) 6, and prostate specific antigen (psa) < 10 ng/ml)
    boolean
    C1300072 (UMLS CUI [1])
    C3203027 (UMLS CUI [2])
    C0138741 (UMLS CUI [3])
    tumor stage; gleason score; prostate specific antigen
    Item
    low-tier intermediate risk disease (ct2c,gs=6,and psa 10-15 ng/ml, or gs=7 and psa < 10 ng/ml)
    boolean
    C1300072 (UMLS CUI [1])
    C3203027 (UMLS CUI [2])
    C0138741 (UMLS CUI [3])
    Antiandrogen therapy; positive biopsy cores; tumor stage; gleason score; prostate specific antigen
    Item
    intermediate risk disease and androgen deprivation therapy recommended by the treating physician for oncologic reasons such as (≥ 50% positive biopsy cores,ct2c,psa 15-20 ng/ml,gs=7)
    boolean
    C0279492 (UMLS CUI [1])
    C1276779 (UMLS CUI [2])
    C1300072 (UMLS CUI [3])
    C3203027 (UMLS CUI [4])
    C0138741 (UMLS CUI [5])
    trans-rectal ultrasound prostate volume for prostate brachytherapy; androgen ablation
    Item
    patient requires baseline planning trans-rectal ultrasound for the purposes of prostate brachytherapy, showing prostate volume > 40 ml and pubic arch interference (not required for those requiring androgen ablation for oncologic reasons)
    boolean
    C0812546 (UMLS CUI [1])
    C1515985 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    serum testosterone
    Item
    castrate serum testosterone level
    boolean
    C0428413 (UMLS CUI [1])
    pelvic radiotherapy
    Item
    previous or concurrent pelvic radiotherapy
    boolean
    C0436276 (UMLS CUI [1])
    informed consent
    Item
    unable to give written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    prostate brachytherapy; Antiandrogen therapy
    Item
    contraindications to permanent seed prostate brachytherapy or to androgen deprivation therapy
    boolean
    C0854662 (UMLS CUI [1])
    C0279492 (UMLS CUI [2])
    Study Subject Participation Status
    Item
    prior treatment for prostate cancer
    boolean
    C2348568 (UMLS CUI [1])
    Transurethral Resection of Prostate
    Item
    prior trans-urethral resection of the prostate
    boolean
    C0040771 (UMLS CUI [1])
    therapy 5-alpha Reductase Inhibitors Androgen Antagonists; Luteinizing Hormone-releasing Hormone Agonist
    Item
    previous therapy with a 5-α reductase inhibitor, anti-androgen agent, or lhrh agonist
    boolean
    C0087111 (UMLS CUI [1,1])
    C2936788 (UMLS CUI [1,2])
    C0002842 (UMLS CUI [1,3])
    C1518041 (UMLS CUI [1,4])
    therapy degarelix
    Item
    previous therapy with degarelix
    boolean
    C0087111 (UMLS CUI [1,1])
    C1455035 (UMLS CUI [1,2])

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