0 Evaluaciones

ID

13618

Descripción

Intermittent Hormonal Therapy With Leuprorelin and Flutamide in the Treatment of Stage D2 or TxNxM1b,c; ODM derived from: https://clinicaltrials.gov/show/NCT00817739

Link

https://clinicaltrials.gov/show/NCT00817739

Palabras clave

  1. 20/2/16 20/2/16 -
Subido en

20 de febrero de 2016

DOI

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Licencia

Creative Commons BY 4.0

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    Eligibility Prostatic Neoplasms NCT00817739

    Eligibility Prostatic Neoplasms NCT00817739

    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically confirmed metastatic cancer of the prostate (stage d2 or tx nx m1 ≠ m1a)
    Descripción

    prostate cancer, metastastic disease, tumor stage

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0600139
    UMLS CUI [2]
    C0027627
    UMLS CUI [3]
    C1300072
    with measurable bone or visceral (lung, liver, etc.) metastases (radiographic conformation was necessary in the event of a questionable bone scan detection in conjunction with only slightly elevated psa levels [at least 20 ng/ml or less than or equal to 50 ng/ml]). the prostatic carcinoma could have been diagnosed at an earlier stage and treated without castration.
    Descripción

    measurable metastases, psa levels

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0027627
    UMLS CUI [2]
    C1513041
    UMLS CUI [3]
    C0138741
    pre-assessment psa 5-fold or higher than the standard level set by the central laboratory, that is, psa greater than or equal to (≥) 20 ng/ml as quantitated by the hybritech radioimmunoassay (normal is less than [<] 4 ng/ml).
    Descripción

    pre-assessment psa

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0138741
    ecog performance status of no more than 2.
    Descripción

    performance status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    normal testosterone levels according to the central laboratory standards.
    Descripción

    testosterone level

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0039601
    aspartate transaminase (ast) and alanine transaminase (alt) < 2.25-fold higher than the standard levels set by the central laboratory (except when liver metastases were present).
    Descripción

    Ast and alt

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    UMLS CUI [2]
    C0201899
    anticipated life expectancy greater than 9 months.
    Descripción

    life expectancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    written informed consent given to participate and collaborate in the study. inclusion criteria for continuous or intermittent treatment phase
    Descripción

    informed consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    subjects who meet the pre-assessment criteria and who has psa < 4 ng/ml after 6 months of induction therapy.
    Descripción

    meets inclusion criteria, psa levels

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    UMLS CUI [2]
    C0138741
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    subject refuse to sign the informed consent form or is likely to be uncooperative or not to comply with the obligations set out in the study protocol.
    Descripción

    refuse to sign the informed consent, compliance limited

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    subject has received prior hormonal (and neoadjuvant) treatment prompting medical castration (estrogens, hormone-releasing hormone agonists, androgens) or has undergone surgical castration.
    Descripción

    prior therapy resulting in castration

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0007344
    UMLS CUI [2]
    C0455189
    UMLS CUI [3]
    C1514463
    subject has undergone bilateral suprarenalectomy or hypophysectomy.
    Descripción

    bilateral suprarenalectomy or hypophysectomy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0020632
    UMLS CUI [2]
    C0193667
    subject had another cancer (except basiloma) with the past 5 years.
    Descripción

    malignancies

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    subject has serious unstable progressive disease (renal, hepatic, cardiovascular, psychological, etc).
    Descripción

    serious unstable progressive disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    subject is receiving or has received another experimental treatment within 3 months prior to inclusion.
    Descripción

    prior experimental therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0949266
    exclusion criteria for continuous or intermittent treatment phase
    Descripción

    exclusion criteria for continuous or intermittent treatment phase

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    subjects who met the pre-assessment criteria and who, after 6 months of induction therapy, had psa ≥ 4 ng/ml and/or on-treatment signs of disease progression.
    Descripción

    pre-assessment criteria met, psa levels too high

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    UMLS CUI [2]
    C0138741

    Similar models

    Eligibility Prostatic Neoplasms NCT00817739

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    prostate cancer, metastastic disease, tumor stage
    Item
    histologically confirmed metastatic cancer of the prostate (stage d2 or tx nx m1 ≠ m1a)
    boolean
    C0600139 (UMLS CUI [1])
    C0027627 (UMLS CUI [2])
    C1300072 (UMLS CUI [3])
    measurable metastases, psa levels
    Item
    with measurable bone or visceral (lung, liver, etc.) metastases (radiographic conformation was necessary in the event of a questionable bone scan detection in conjunction with only slightly elevated psa levels [at least 20 ng/ml or less than or equal to 50 ng/ml]). the prostatic carcinoma could have been diagnosed at an earlier stage and treated without castration.
    boolean
    C0027627 (UMLS CUI [1])
    C1513041 (UMLS CUI [2])
    C0138741 (UMLS CUI [3])
    pre-assessment psa
    Item
    pre-assessment psa 5-fold or higher than the standard level set by the central laboratory, that is, psa greater than or equal to (≥) 20 ng/ml as quantitated by the hybritech radioimmunoassay (normal is less than [<] 4 ng/ml).
    boolean
    C0138741 (UMLS CUI [1])
    performance status
    Item
    ecog performance status of no more than 2.
    boolean
    C1520224 (UMLS CUI [1])
    testosterone level
    Item
    normal testosterone levels according to the central laboratory standards.
    boolean
    C0039601 (UMLS CUI [1])
    Ast and alt
    Item
    aspartate transaminase (ast) and alanine transaminase (alt) < 2.25-fold higher than the standard levels set by the central laboratory (except when liver metastases were present).
    boolean
    C0201836 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    life expectancy
    Item
    anticipated life expectancy greater than 9 months.
    boolean
    C0023671 (UMLS CUI [1])
    informed consent
    Item
    written informed consent given to participate and collaborate in the study. inclusion criteria for continuous or intermittent treatment phase
    boolean
    C0021430 (UMLS CUI [1])
    meets inclusion criteria, psa levels
    Item
    subjects who meet the pre-assessment criteria and who has psa < 4 ng/ml after 6 months of induction therapy.
    boolean
    C1512693 (UMLS CUI [1])
    C0138741 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    refuse to sign the informed consent, compliance limited
    Item
    subject refuse to sign the informed consent form or is likely to be uncooperative or not to comply with the obligations set out in the study protocol.
    boolean
    C1321605 (UMLS CUI [1])
    prior therapy resulting in castration
    Item
    subject has received prior hormonal (and neoadjuvant) treatment prompting medical castration (estrogens, hormone-releasing hormone agonists, androgens) or has undergone surgical castration.
    boolean
    C0007344 (UMLS CUI [1])
    C0455189 (UMLS CUI [2])
    C1514463 (UMLS CUI [3])
    bilateral suprarenalectomy or hypophysectomy
    Item
    subject has undergone bilateral suprarenalectomy or hypophysectomy.
    boolean
    C0020632 (UMLS CUI [1])
    C0193667 (UMLS CUI [2])
    malignancies
    Item
    subject had another cancer (except basiloma) with the past 5 years.
    boolean
    C0006826 (UMLS CUI [1])
    serious unstable progressive disease
    Item
    subject has serious unstable progressive disease (renal, hepatic, cardiovascular, psychological, etc).
    boolean
    C0009488 (UMLS CUI [1])
    prior experimental therapy
    Item
    subject is receiving or has received another experimental treatment within 3 months prior to inclusion.
    boolean
    C0949266 (UMLS CUI [1])
    exclusion criteria for continuous or intermittent treatment phase
    Item
    exclusion criteria for continuous or intermittent treatment phase
    boolean
    C0680251 (UMLS CUI [1])
    pre-assessment criteria met, psa levels too high
    Item
    subjects who met the pre-assessment criteria and who, after 6 months of induction therapy, had psa ≥ 4 ng/ml and/or on-treatment signs of disease progression.
    boolean
    C1512693 (UMLS CUI [1])
    C0138741 (UMLS CUI [2])

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