ID

31498

Description

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

Link

https://clinicaltrials.gov/show/NCT01022515

Keywords

Versions (1)
  1. 8/28/18 8/28/18 -
Copyright Holder

See clinicaltrials.gov

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August 28, 2018

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License

Creative Commons BY 4.0
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Eligibility Pheochromocytoma NCT01022515

English

Eligibility Pheochromocytoma NCT01022515

1 forms  
Criteria
Description

Criteria

inclusion criteria :
Description

Inclusion criteria

Data type

boolean

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

Age

Data type

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)
Description

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

Data type

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) ,
Description

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

Data type

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
Description

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

Data type

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
Description

Informed Consent

Data type

boolean

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

Patients Medical insurance | Exclusion Criteria

Data type

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.
Description

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

Data type

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.
Description

Patients In prison | Patients Protection Legal

Data type

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
Description

Essential Hypertension | Inclusion criteria

Data type

boolean

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

Age

Data type

boolean

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

Relationship Patient Pheochromocytoma | Relationship Patient Paraganglioma | Gender | Age

Data type

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.
Description

Hypertensive disease | Etiology Unknown

Data type

boolean

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

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

Data type

boolean

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

Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test negative

Data type

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
Description

Informed Consent

Data type

boolean

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

Patients Medical insurance | Exclusion Criteria

Data type

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
Description

Proton Pump Inhibitors

Data type

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)
Description

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

Data type

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.
Description

Patients In prison | Patients Protection Legal

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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