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Salivary, plasma metanephrines and anxiety levels in pheochromocytomas


- candidate number21717
- NTR NumberNTR5066
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-feb-2015
- Secondary IDsNL50957.042.14 ABR
- Public TitleSalivary, plasma metanephrines and anxiety levels in pheochromocytomas
- Scientific TitleSalivary, plasma meTanephRines and anxiEty levelS in pheochromocytomaS
- ACRONYMSTRESS
- hypothesis1. Measurement of salivary metanephrines is just as accurate as plasma metanephrines in detecting a pheochromocytoma or sympathetic paraganglioma.
2. Anxiety levels are elevated in patients with a pheochromocytoma or sympathetic paraganglioma
- Healt Condition(s) or Problem(s) studiedPheochromocytoma, Paraganglioma, Diagnosis, Metanephrines
- Inclusion criteriaPatients (age > 18 years) with a pheochromocytoma or sympathetic paraganglioma, with elevated plasma metanephrines AND
Germline mutation carriers without elevated plasma metanephrines AND Healthy subjects
- Exclusion criteriaThe need to use medication known to influence plasma metanephrines concentration: tricyclic antidepressants, phenoxybenzamine, MAO-inhibitors, sympathomimetics, cocaine, methyldopa
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-apr-2015
- planned closingdate1-apr-2017
- Target number of participants435
- InterventionsCollecting saliva and collecting 20 ml blood. Filling out a anxiety questionnaire
- Primary outcomeThe diagnostic accuracy (sensitivity and specificity) of salivary levels of metanephrines
- Secondary outcome1. 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.
- TimepointsNot applicable
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD24-feb-2015 - 19-apr-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl