Information:
Fel:
ID
31498
Beskrivning
Specificity of Elevated Plasma EM66 Levels in Pheochromocytoma; ODM derived from: https://clinicaltrials.gov/show/NCT01022515
Länk
https://clinicaltrials.gov/show/NCT01022515
Nyckelord
Versioner (1)
- 2018-08-28 2018-08-28 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
28 augusti 2018
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Pheochromocytoma NCT01022515
Eligibility Pheochromocytoma NCT01022515
- StudyEvent: Eligibility
Similar models
Eligibility Pheochromocytoma NCT01022515
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0392751 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1545588 (UMLS CUI [2,2])
C1301860 (UMLS CUI [2,3])
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