0 Avaliações
ID

31498

Descrição

Specificity of Elevated Plasma EM66 Levels in Pheochromocytoma; ODM derived from: https://clinicaltrials.gov/show/NCT01022515

Link

https://clinicaltrials.gov/show/NCT01022515

Palavras-chave

Versões (1)
  1. 28/08/2018 28/08/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

28 août 2018

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Pheochromocytoma NCT01022515

    Inglês

    Eligibility Pheochromocytoma NCT01022515

    1 Formulários  
    Criteria
    Descrição

    Criteria

    inclusion criteria :
    Descrição

    Inclusion criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    men & women, age > 18 years old
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    newly diagnosed patient : suspicion of pheochromocytoma or paraganglioma with elevation of urinary metanephrines and/or normetanephrines along with evidence of tumor which surgical removal is considered (histological findings following surgery will be the gold standard for final diagnosis and inclusion in the study)
    Descrição

    Patient Newly Diagnosed | Suspicion Pheochromocytoma | Suspicion Paraganglioma | Metanephrine urine increased | Normetanephrine urine increased | Evidence of Neoplasm | Excision Under consideration

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1518321
    UMLS CUI [2,1]
    C0242114
    UMLS CUI [2,2]
    C0031511
    UMLS CUI [3,1]
    C0242114
    UMLS CUI [3,2]
    C0030421
    UMLS CUI [4]
    C0542089
    UMLS CUI [5]
    C0877142
    UMLS CUI [6,1]
    C0332120
    UMLS CUI [6,2]
    C0027651
    UMLS CUI [7,1]
    C0728940
    UMLS CUI [7,2]
    C1272681
    during follow-up of a patient with known genetic predisposition to pheochromocytoma/paraganglioma : suspicion of pheochromocytoma or paraganglioma with or without elevation of urinary metanephrines and/or normetanephrines along with evidence of a tumor which surgical removal is considered (histological findings following surgery will be the gold standard for final diagnosis and inclusion in the study) ,
    Descrição

    Patient Follow-up | Genetic Predisposition Pheochromocytoma | Genetic Predisposition Paraganglioma | Suspicion Pheochromocytoma | Suspicion Paraganglioma | Metanephrine urine increased | Normetanephrine urine increased | Metanephrine urine increased Absent | Normetanephrine urine increased Absent | Evidence of Neoplasm | Excision Under consideration

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C3274571
    UMLS CUI [2,1]
    C0314657
    UMLS CUI [2,2]
    C0031511
    UMLS CUI [3,1]
    C0314657
    UMLS CUI [3,2]
    C0030421
    UMLS CUI [4,1]
    C0242114
    UMLS CUI [4,2]
    C0031511
    UMLS CUI [5,1]
    C0242114
    UMLS CUI [5,2]
    C0030421
    UMLS CUI [6]
    C0542089
    UMLS CUI [7]
    C0877142
    UMLS CUI [8,1]
    C0542089
    UMLS CUI [8,2]
    C0332197
    UMLS CUI [9,1]
    C0877142
    UMLS CUI [9,2]
    C0332197
    UMLS CUI [10,1]
    C0332120
    UMLS CUI [10,2]
    C0027651
    UMLS CUI [11,1]
    C0728940
    UMLS CUI [11,2]
    C1272681
    patients with known pheochromocytoma/paraganglioma, whether malignant or not, whether with metanephrine secretion or not, with tumor sites at inclusion in the study
    Descrição

    Pheochromocytoma, malignant | Malignant Paraganglionic Neoplasm | Pheochromocytoma | Paraganglioma | Metanephrine Secretion | Metanephrine Secretion Absent | Tumor site Present

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0334419
    UMLS CUI [2]
    C1533592
    UMLS CUI [3]
    C0031511
    UMLS CUI [4]
    C0030421
    UMLS CUI [5,1]
    C0025562
    UMLS CUI [5,2]
    C0036536
    UMLS CUI [6,1]
    C0025562
    UMLS CUI [6,2]
    C0036536
    UMLS CUI [6,3]
    C0332197
    UMLS CUI [7,1]
    C0475445
    UMLS CUI [7,2]
    C0150312
    patients informed and willing to participate in the study
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    patients with medical insurance (french social security) non inclusion criteria
    Descrição

    Patients Medical insurance | Exclusion Criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0481840
    UMLS CUI [2]
    C0680251
    patients newly diagnosed, recently operated and the histological findings disprove pheochromocytoma or paraganglioma.
    Descrição

    Patients Newly Diagnosed | Recent surgery | Pheochromocytoma Refuted | Paraganglioma Refuted

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1518321
    UMLS CUI [2]
    C2169607
    UMLS CUI [3,1]
    C0031511
    UMLS CUI [3,2]
    C4509936
    UMLS CUI [4,1]
    C0030421
    UMLS CUI [4,2]
    C4509936
    patient imprisoned or under legal protection.
    Descrição

    Patients In prison | Patients Protection Legal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0392751
    UMLS CUI [2,1]
    C0030705
    UMLS CUI [2,2]
    C1545588
    UMLS CUI [2,3]
    C1301860
    patients with essential hypertension inclusion criteria
    Descrição

    Essential Hypertension | Inclusion criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0085580
    UMLS CUI [2]
    C1512693
    men & women, age > 18 years old
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    paired with a patient with pheochromocytoma/paraganglioma for : gender, age (± 5 years) and centre
    Descrição

    Relationship Patient Pheochromocytoma | Relationship Patient Paraganglioma | Gender | Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0439849
    UMLS CUI [1,2]
    C0030705
    UMLS CUI [1,3]
    C0031511
    UMLS CUI [2,1]
    C0439849
    UMLS CUI [2,2]
    C0030705
    UMLS CUI [2,3]
    C0030421
    UMLS CUI [3]
    C0079399
    UMLS CUI [4]
    C0001779
    patient with hypertension. no aetiology was found after initial check up.
    Descrição

    Hypertensive disease | Etiology Unknown

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0020538
    UMLS CUI [2,1]
    C0015127
    UMLS CUI [2,2]
    C0439673
    normal 24 hours urinary excretion of metanephrines & normetanephrines
    Descrição

    24-hour urine total metanephrine measurement | 24 hour urine normetanephrine output

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2182731
    UMLS CUI [2]
    C1272101
    for women of childbearing potential : effective contraceptive method and negative urinary pregnancy test
    Descrição

    Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test negative

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0430057
    patients informed and willing to participate in the study
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    patients with medical insurance (french social security) non inclusion criteria
    Descrição

    Patients Medical insurance | Exclusion Criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0481840
    UMLS CUI [2]
    C0680251
    treatment with proton-pump inhibitors in the 8 days before inclusion in the study
    Descrição

    Proton Pump Inhibitors

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0358591
    treatment with beta-blockers, antidepressants, benzodiazepins, dopa, alphamethyl dopa, if this treatment cannot be interrupted during the study (i.e. for approximately 10 days)
    Descrição

    Adrenergic beta-Antagonists | Antidepressive Agents | Benzodiazepines | Dopa | Methyldopa

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001645
    UMLS CUI [2]
    C0003289
    UMLS CUI [3]
    C0005064
    UMLS CUI [4]
    C0013023
    UMLS CUI [5]
    C0025741
    patient imprisoned or under legal protection.
    Descrição

    Patients In prison | Patients Protection Legal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0392751
    UMLS CUI [2,1]
    C0030705
    UMLS CUI [2,2]
    C1545588
    UMLS CUI [2,3]
    C1301860
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    Similar models

    Eligibility Pheochromocytoma NCT01022515

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Inclusion criteria
    Item
    inclusion criteria :
    boolean
    C1512693 (UMLS CUI [1])
    Age
    Item
    men & women, age > 18 years old
    boolean
    C0001779 (UMLS CUI [1])
    Patient Newly Diagnosed | Suspicion Pheochromocytoma | Suspicion Paraganglioma | Metanephrine urine increased | Normetanephrine urine increased | Evidence of Neoplasm | Excision Under consideration
    Item
    newly diagnosed patient : suspicion of pheochromocytoma or paraganglioma with elevation of urinary metanephrines and/or normetanephrines along with evidence of tumor which surgical removal is considered (histological findings following surgery will be the gold standard for final diagnosis and inclusion in the study)
    boolean
    C0030705 (UMLS CUI [1,1])
    C1518321 (UMLS CUI [1,2])
    C0242114 (UMLS CUI [2,1])
    C0031511 (UMLS CUI [2,2])
    C0242114 (UMLS CUI [3,1])
    C0030421 (UMLS CUI [3,2])
    C0542089 (UMLS CUI [4])
    C0877142 (UMLS CUI [5])
    C0332120 (UMLS CUI [6,1])
    C0027651 (UMLS CUI [6,2])
    C0728940 (UMLS CUI [7,1])
    C1272681 (UMLS CUI [7,2])
    Patient Follow-up | Genetic Predisposition Pheochromocytoma | Genetic Predisposition Paraganglioma | Suspicion Pheochromocytoma | Suspicion Paraganglioma | Metanephrine urine increased | Normetanephrine urine increased | Metanephrine urine increased Absent | Normetanephrine urine increased Absent | Evidence of Neoplasm | Excision Under consideration
    Item
    during follow-up of a patient with known genetic predisposition to pheochromocytoma/paraganglioma : suspicion of pheochromocytoma or paraganglioma with or without elevation of urinary metanephrines and/or normetanephrines along with evidence of a tumor which surgical removal is considered (histological findings following surgery will be the gold standard for final diagnosis and inclusion in the study) ,
    boolean
    C0030705 (UMLS CUI [1,1])
    C3274571 (UMLS CUI [1,2])
    C0314657 (UMLS CUI [2,1])
    C0031511 (UMLS CUI [2,2])
    C0314657 (UMLS CUI [3,1])
    C0030421 (UMLS CUI [3,2])
    C0242114 (UMLS CUI [4,1])
    C0031511 (UMLS CUI [4,2])
    C0242114 (UMLS CUI [5,1])
    C0030421 (UMLS CUI [5,2])
    C0542089 (UMLS CUI [6])
    C0877142 (UMLS CUI [7])
    C0542089 (UMLS CUI [8,1])
    C0332197 (UMLS CUI [8,2])
    C0877142 (UMLS CUI [9,1])
    C0332197 (UMLS CUI [9,2])
    C0332120 (UMLS CUI [10,1])
    C0027651 (UMLS CUI [10,2])
    C0728940 (UMLS CUI [11,1])
    C1272681 (UMLS CUI [11,2])
    Pheochromocytoma, malignant | Malignant Paraganglionic Neoplasm | Pheochromocytoma | Paraganglioma | Metanephrine Secretion | Metanephrine Secretion Absent | Tumor site Present
    Item
    patients with known pheochromocytoma/paraganglioma, whether malignant or not, whether with metanephrine secretion or not, with tumor sites at inclusion in the study
    boolean
    C0334419 (UMLS CUI [1])
    C1533592 (UMLS CUI [2])
    C0031511 (UMLS CUI [3])
    C0030421 (UMLS CUI [4])
    C0025562 (UMLS CUI [5,1])
    C0036536 (UMLS CUI [5,2])
    C0025562 (UMLS CUI [6,1])
    C0036536 (UMLS CUI [6,2])
    C0332197 (UMLS CUI [6,3])
    C0475445 (UMLS CUI [7,1])
    C0150312 (UMLS CUI [7,2])
    Informed Consent
    Item
    patients informed and willing to participate in the study
    boolean
    C0021430 (UMLS CUI [1])
    Patients Medical insurance | Exclusion Criteria
    Item
    patients with medical insurance (french social security) non inclusion criteria
    boolean
    C0030705 (UMLS CUI [1,1])
    C0481840 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [2])
    Patients Newly Diagnosed | Recent surgery | Pheochromocytoma Refuted | Paraganglioma Refuted
    Item
    patients newly diagnosed, recently operated and the histological findings disprove pheochromocytoma or paraganglioma.
    boolean
    C0030705 (UMLS CUI [1,1])
    C1518321 (UMLS CUI [1,2])
    C2169607 (UMLS CUI [2])
    C0031511 (UMLS CUI [3,1])
    C4509936 (UMLS CUI [3,2])
    C0030421 (UMLS CUI [4,1])
    C4509936 (UMLS CUI [4,2])
    Patients In prison | Patients Protection Legal
    Item
    patient imprisoned or under legal protection.
    boolean
    C0030705 (UMLS CUI [1,1])
    C0392751 (UMLS CUI [1,2])
    C0030705 (UMLS CUI [2,1])
    C1545588 (UMLS CUI [2,2])
    C1301860 (UMLS CUI [2,3])
    Essential Hypertension | Inclusion criteria
    Item
    patients with essential hypertension inclusion criteria
    boolean
    C0085580 (UMLS CUI [1])
    C1512693 (UMLS CUI [2])
    Age
    Item
    men & women, age > 18 years old
    boolean
    C0001779 (UMLS CUI [1])
    Relationship Patient Pheochromocytoma | Relationship Patient Paraganglioma | Gender | Age
    Item
    paired with a patient with pheochromocytoma/paraganglioma for : gender, age (± 5 years) and centre
    boolean
    C0439849 (UMLS CUI [1,1])
    C0030705 (UMLS CUI [1,2])
    C0031511 (UMLS CUI [1,3])
    C0439849 (UMLS CUI [2,1])
    C0030705 (UMLS CUI [2,2])
    C0030421 (UMLS CUI [2,3])
    C0079399 (UMLS CUI [3])
    C0001779 (UMLS CUI [4])
    Hypertensive disease | Etiology Unknown
    Item
    patient with hypertension. no aetiology was found after initial check up.
    boolean
    C0020538 (UMLS CUI [1])
    C0015127 (UMLS CUI [2,1])
    C0439673 (UMLS CUI [2,2])
    24-hour urine total metanephrine measurement | 24 hour urine normetanephrine output
    Item
    normal 24 hours urinary excretion of metanephrines & normetanephrines
    boolean
    C2182731 (UMLS CUI [1])
    C1272101 (UMLS CUI [2])
    Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test negative
    Item
    for women of childbearing potential : effective contraceptive method and negative urinary pregnancy test
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C3831118 (UMLS CUI [2,1])
    C0430057 (UMLS CUI [2,2])
    Informed Consent
    Item
    patients informed and willing to participate in the study
    boolean
    C0021430 (UMLS CUI [1])
    Patients Medical insurance | Exclusion Criteria
    Item
    patients with medical insurance (french social security) non inclusion criteria
    boolean
    C0030705 (UMLS CUI [1,1])
    C0481840 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [2])
    Proton Pump Inhibitors
    Item
    treatment with proton-pump inhibitors in the 8 days before inclusion in the study
    boolean
    C0358591 (UMLS CUI [1])
    Adrenergic beta-Antagonists | Antidepressive Agents | Benzodiazepines | Dopa | Methyldopa
    Item
    treatment with beta-blockers, antidepressants, benzodiazepins, dopa, alphamethyl dopa, if this treatment cannot be interrupted during the study (i.e. for approximately 10 days)
    boolean
    C0001645 (UMLS CUI [1])
    C0003289 (UMLS CUI [2])
    C0005064 (UMLS CUI [3])
    C0013023 (UMLS CUI [4])
    C0025741 (UMLS CUI [5])
    Patients In prison | Patients Protection Legal
    Item
    patient imprisoned or under legal protection.
    boolean
    C0030705 (UMLS CUI [1,1])
    C0392751 (UMLS CUI [1,2])
    C0030705 (UMLS CUI [2,1])
    C1545588 (UMLS CUI [2,2])
    C1301860 (UMLS CUI [2,3])
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