To determine the sensitivity and specificity of salivary metanephrines and in patients with PCC/sPGL.
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the diagnostic accuracy (sensitivity and
specificity) of salivary levels of metanephrines assuming that the sensivity
and specificity will be 95% (95% Confidence Interval (CI) 90-98%).
Secondary outcome
1. To evaluate the self-reported anxiety levels in patients with a PCC/sPGL, in
comparison with healthy subjects and germline mutation carriers without
elevated plasma metanephrines levels and to correlate the anxiety levels to the
plasma metanephrines levels
2. To determine whether position (sitting vs. supine position) influences
salivary metanephrines levels.
3. To establish a reference set for plasma and salivary metanephrines in supine
position after 30 minutes of rest
4. To compare the ROC curves for the PCC/sPGL patients with the ROC curve of
salivary and plasma metanephrines of asymptomatic germline mutation carriers.
5. To compare the concentration of metanephrines and catecholamines collected
by venapunction versus a blood sample collected by an indwelling intravenous
catheter
6. To establish a reference set of plasma catecholamines in supine position
after 30 minutes of rest, and after 5 minutes of sitting
Background summary
Measurement of the O-methylated metabolites of plasma catecholamines (i.e.
metanephrines) is the cornerstone in diagnosing pheochromocytoma (PCC) and
sympathetic paragangliomas (sPGL)s. Levels of plasma metanephrines are,
however, affected by body position during blood sampling. Therefore patients
need to rest for 20 to 30 minutes in supine position before blood sampling.
Measurement of levels of metanephrines in saliva could be an alternative, less
cumbersome method, which also offers the advantage of collecting a diagnostic
sample at home. Therefore, measurement of metanephrines in saliva is expected
to be a novel, sensitive and more patient friendly method for the detection of
PCC/sPGL. Furthermore catecholamines are involved in the physical sensations
experienced in anxiety. Patients with PCC/sPGL have high levels of
catecholamines, but anxiety levels never have been investigated.
Moreover, there are different methods to draw blood for the determination of
plasma metanefrine levels, via indwelling catheter or via venapuncture, these
differences never has been investigated.
Recently, the UMCG developed a new liquid chromatography in combination with
isotope dilution mass spectrometry method for the simultaneous quantification
of catecholamines (adrenaline, noradrenaline and dopamine) and metanephrines.
This investigation is helpfull in the diagnosis of autonomic diseases, but
reference levels are not established yet.
Study objective
To determine the sensitivity and specificity of salivary metanephrines and in
patients with PCC/sPGL.
Study design
This study is a cross-sectional 2 center study performed at the University
Medical Center Groningen (UMCG), Groningen, the Netherlands, at the National
Institute of Health (NIH), Bethesda, USA and at the Radboud University Medical
Center Nijmegen, the Netherlands
Study burden and risks
There is no or only one extra visit to the hospital and the study will take
about 1 hour additional time. The medical risks and the burden for the patients
and healthy subjects are considered to be minimal. If measurement of salivary
metanephrines is just as accurate as plasma metanephrines is detecting a
PCC/sPGL, this is time/costs effective for both patients and the hospital.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL50957.042.14 |
| Other | registratie verzoek ingediend NTR |
| OMON | NL-OMON20291 |