Salivary, plasma metanephrines and anxiety levels in pheochromocytomas

Completed

Conditions: adrenal tumor
pheochromocytoma
10001353

Registration Number: NL-OMON43844

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 315

Inclusion Criteria

Age > 18 years
Group I: Patients with a PCC, or sPGL :
1. elevated plasma and/or urinary (nor)metanephrines
2. localization of a PCC or sPGL by anatomical (MRI/CT) and functional imaging (123I-metaiodobenzylguanidin (MIBG) scintigraphy or 18F-dihydrophenylalanine (DOPA) positron emission tomography (PET) or 18F-fluorodopamine PET.
Group II: Germline mutation carriers
1. plasma metanephrines in the normal reference range
Group III: Healthy subjects
1. normotensive.
2. no documented cardiovascular history (including: hypertension, diabetes, coronary artery disease, peripheral vascular disease),

Exclusion Criteria

1. Age < 18 years
2. The need to use medication known to influence plasma metanephrines concentration: tricyclic antidepressants, phenoxybenzamine, MAO-inhibitors, sympathomimetics, cocaine, methyldopa
3. Patient who are operated on (after inclusion) and histology shows no PCC or sPGL
4. Patients, mutation carriers and healthy subjects who are not able to read and understand the Dutch language are not eligble for filling out the anxiety questionnair
5. Patient,mutation carriers and healthy subjects with severe psychiatric co-morbidity (i.e. acute suicidal ideations or behaviour, recently experienced psychosis, diagnosis of schizophrenia, bipolar disorder, drug abuse or substance dependence, serious cognitive or neurological problems) are not eligible for filling out the anxiety questionnaire.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the diagnostic accuracy (sensitivity and<br /><br>specificity) of salivary levels of metanephrines assuming that the sensivity<br /><br>and specificity will be 95% (95% Confidence Interval (CI) 90-98%).</p><br>

Secondary Outcome Measures