0 Evaluaciones
ID

14617

Descripción

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00005947

Link

https://clinicaltrials.gov/show/NCT00005947

Palabras clave

Versiones (1)
  1. 24/4/16 24/4/16 -
Subido en

24 de abril de 2016

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Prostate Cancer NCT00005947

    Inglés

    Eligibility Prostate Cancer NCT00005947

    1 formularios  
    Criteria
    Descripción

    Criteria

    metastatic disease as evidenced by soft tissue and/or bony metastases.
    Descripción

    Metastatic prostate cancer

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0936223 (Metastatic Prostate Carcinoma)
    baseline psa value of at least 5 ng/ml. all subjects must have stable or rising psa.
    Descripción

    PSA measurement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0201544 (Prostate specific antigen measurement)
    SNOMED
    63476009
    tumor progression after hormonal therapy.
    Descripción

    Tumor progression after hormonal therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0178874 (Tumor Progression)
    SNOMED
    419835002
    UMLS CUI [1,2]
    C0279025 (Hormone Therapy)
    SNOMED
    169413002
    hormonal therapy consisting of castration by orchiectomy or lhrh agonists for treatment of prostate cancer. castration levels of testosterone (< 50 ng/dl) must be documented for all subjects including subjects who underwent orchiectomy as therapy for cancer of the prostate.
    Descripción

    Hormone therapy: specification

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0029189 (Orchiectomy)
    SNOMED
    236334001
    UMLS CUI [2]
    C1518041 (Luteinizing Hormone-releasing Hormone Agonist)
    UMLS CUI [3]
    C0202227 (Total Testosterone Measurement)
    SNOMED
    85470006
    a subject is eligible if he initially responded to antiandrogen withdrawal (> 25% decrease in psa) but at the time of registration demonstrated tumor progression. a subject is eligible if he failed to respond to antiandrogen withdrawal.
    Descripción

    Antiandrogen therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0002842 (Androgen Antagonists)
    SNOMED
    103024009
    UMLS CUI [1,2]
    C0683154 (drug response)
    subjects have no cancer-related pain and do not regularly require analgesics for cancer-related pain.
    Descripción

    Cancer-related pain and analgesics

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1719395 (Pain due to neoplastic disease)
    SNOMED
    98921000119102
    UMLS CUI [2]
    C0002771 (Analgesics)
    SNOMED
    53009005
    LOINC
    LP31483-8
    ecog performance status of 0 or 1.
    Descripción

    ECOG performance status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    life expectancy of at least 16 weeks.
    Descripción

    Life expectancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    adequate hematologic, renal, and liver function.
    Descripción

    Hematologic, renal, and liver function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0221130 (Hematologic function)
    SNOMED
    86084001
    UMLS CUI [2]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [3]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    exclusion criteria include:
    Descripción

    Exclusion criteria

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0680251 (Exclusion Criteria)
    visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites).
    Descripción

    Visceral organ metastases and effusions

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    UMLS CUI [1,2]
    C0442045 (Visceral)
    SNOMED
    263928002
    UMLS CUI [2]
    C0013687 (effusion)
    SNOMED
    41699000
    metastatic disease expected to be in need of radiation therapy within 4 months.
    Descripción

    Metastatic disease need radiotherapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    UMLS CUI [1,2]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    concurrent therapy with experimental agents.
    Descripción

    Experimental drugs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0304229 (Experimental drug)
    systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any reason other than treatment of prostate cancer within the previous 6 months without prior approval.
    Descripción

    Systemic corticosteroids daily dose

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2825233 (systemic steroids)
    UMLS CUI [1,2]
    C2348070 (Daily Dose)
    please note that there are additional eligibility criteria. the study center will determine if you meet all of the criteria.
    Descripción

    Eligibility criteria

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1516637 (Clinical Trial Eligibility Criteria)
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    Similar models

    Eligibility Prostate Cancer NCT00005947

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Metastatic prostate cancer
    Item
    metastatic disease as evidenced by soft tissue and/or bony metastases.
    boolean
    C0936223 (UMLS CUI [1])
    PSA measurement
    Item
    baseline psa value of at least 5 ng/ml. all subjects must have stable or rising psa.
    boolean
    C0201544 (UMLS CUI [1])
    Tumor progression after hormonal therapy
    Item
    tumor progression after hormonal therapy.
    boolean
    C0178874 (UMLS CUI [1,1])
    C0279025 (UMLS CUI [1,2])
    Hormone therapy: specification
    Item
    hormonal therapy consisting of castration by orchiectomy or lhrh agonists for treatment of prostate cancer. castration levels of testosterone (< 50 ng/dl) must be documented for all subjects including subjects who underwent orchiectomy as therapy for cancer of the prostate.
    boolean
    C0029189 (UMLS CUI [1])
    C1518041 (UMLS CUI [2])
    C0202227 (UMLS CUI [3])
    Antiandrogen therapy
    Item
    a subject is eligible if he initially responded to antiandrogen withdrawal (> 25% decrease in psa) but at the time of registration demonstrated tumor progression. a subject is eligible if he failed to respond to antiandrogen withdrawal.
    boolean
    C0002842 (UMLS CUI [1,1])
    C0683154 (UMLS CUI [1,2])
    Cancer-related pain and analgesics
    Item
    subjects have no cancer-related pain and do not regularly require analgesics for cancer-related pain.
    boolean
    C1719395 (UMLS CUI [1])
    C0002771 (UMLS CUI [2])
    ECOG performance status
    Item
    ecog performance status of 0 or 1.
    boolean
    C1520224 (UMLS CUI [1])
    Life expectancy
    Item
    life expectancy of at least 16 weeks.
    boolean
    C0023671 (UMLS CUI [1])
    Hematologic, renal, and liver function
    Item
    adequate hematologic, renal, and liver function.
    boolean
    C0221130 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    C0232804 (UMLS CUI [3])
    Exclusion criteria
    Item
    exclusion criteria include:
    boolean
    C0680251 (UMLS CUI [1])
    Visceral organ metastases and effusions
    Item
    visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites).
    boolean
    C0027627 (UMLS CUI [1,1])
    C0442045 (UMLS CUI [1,2])
    C0013687 (UMLS CUI [2])
    Metastatic disease need radiotherapy
    Item
    metastatic disease expected to be in need of radiation therapy within 4 months.
    boolean
    C0027627 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    Experimental drugs
    Item
    concurrent therapy with experimental agents.
    boolean
    C0304229 (UMLS CUI [1])
    Systemic corticosteroids daily dose
    Item
    systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any reason other than treatment of prostate cancer within the previous 6 months without prior approval.
    boolean
    C2825233 (UMLS CUI [1,1])
    C2348070 (UMLS CUI [1,2])
    Eligibility criteria
    Item
    please note that there are additional eligibility criteria. the study center will determine if you meet all of the criteria.
    boolean
    C1516637 (UMLS CUI [1])
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