Clinical trial · Interventional
Specificity of Elevated Plasma EM66 Levels in Pheochromocytoma
Clinical Application of New Pheochromocytoma Markers: INSERM Pilot Study of the Specificity of Elevated Plasma EM66 Concentrations in Patients With Pheochromocytoma or Paraganglioma Compared to Patients With Essential Hypertension
NCT01022515CI-TRIAL-00102679PHEOcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pheochromocytoma or paraganglioma are tumors generating hypertension as a symptom. Different biological tests are currently available to diagnose these tumors. However, they all lack specificity since they do not distinguish cases of hypertension without pheochromocytoma or paraganglioma. To improve the diagnostic specificity of these tumors, the investigators are testing a new marker called EM66.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Essential Hypertension | — | UNRESOLVED | — |
| Paraganglioma | Paraganglioma | ONTOLOGY_EXACT | 0.98 |
| Pheochromocytoma | Adrenal Gland Pheochromocytoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| plasma EM66 & CgA levels assessment | Other | — | UNRESOLVED |
| usual follow up with regular EM66 & Cga levels assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- patients with pheochromocytoma
- description
- Patients with pheochromocytoma / paraganglioma are being followed as recommended according to international standards. No intervention is expected except regular measurement of plasma CgA (as usual) and EM66 (research purpose) levels.
- interventionNames
- Other: usual follow up with regular EM66 & Cga levels assessment
- type
- OTHER
- label
- Patients with essential hypertension
- description
- Patients with essential hypertension will be selected as controls. EM66 and CgA plasma levels will be assessed in these patients after having excluded the presence of a pheochromocytoma / paraganglioma with normal urinary metanephrines / normetanephrines excretion levels.
- interventionNames
- Other: plasma EM66 & CgA levels assessment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Patients with pheochromocytoma/paraganglioma Inclusion criteria : * men \& women, age \> 18 years old * 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) * 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) , * Patients with known pheochromocytoma/paraganglioma, whether malignant or not, whether with metanephrine secretion or not, With tumor sites at inclusion in the study * Patients informed and willing to participate in the study * Patients with medical insurance (French social security) Non inclusion criteria * Patients newly diagnosed, recently operated and the histological findings disprove pheochromocytoma or paraganglioma. * patient imprisoned or under legal protection. Patients with essential hypertension Inclusion criteria * men \& women, age \> 18 years old * paired with a patient with pheochromocytoma/paraganglioma for : gender, age (± 5 years) and centre * patient with hypertension. No aetiology was found after initial check up. * Normal 24 hours urinary excretion of metanephrines \& normetanephrines * For women of childbearing potential : effective contraceptive method and negative urinary pregnancy test * Patients informed and willing to participate in the study * Patients with medical insurance (French social security) Non inclusion criteria * Treatment with proton-pump inhibitors in the 8 days before inclusion in the study * Treatment with beta-blockers, antidepressants, Benzodiazepins, dopa, alphamethyl dopa, if this treatment cannot be interrupted during the study (i.e. for approximately 10 days) * patient imprisoned or under legal protection.
References
Publications (0)
Data not yet available
No reference posted for this study.