CClinicalTrials.gg
CompletedNCT01022515PHEOUpdated Feb 6, 2026

Specificity of Elevated Plasma EM66 Levels in Pheochromocytoma

An interventional study of plasma EM66 & CgA levels assessment and usual follow up with regular EM66 & Cga levels assessment in Pheochromocytoma, Paraganglioma and Essential Hypertension, sponsored by University Hospital, Rouen. Completed at 8 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

Read the detailed description

Neuroendocrine tumors (NT) correspond to neoplasms that develop from endocrine and neuroendocrine cells scattered throughout the body. They are characterized by the occurrence, in their cytoplasm, of dense-core secretory vesicles containing hormones, neuropeptides and acidic proteins such as granins. The diversity of NT (from hypophysis, pancreas, adrenal, gastrointestinal tract) makes very difficult the identification and evaluation of the different types of tumors by the diagnostic and prognostic tools currently available. We have thus established a research program aimed at identifying new biological markers for the detection, the prognosis and the follow-up of NT by seeking in tumor and plasma samples of patients, granin-derived peptides. Our program was initiated on one type of NT : pheochromocytoma. These neoplasms correspond to tumoral chromaffin cells mainly originating from the adrenal medulla. It is considered that 10 % of pheochromocytoma patients will develop metastases and, currently, except in the presence of metastases, there are no means to predict malignancy of the tumor. We setup a radioimmunoassay of EM66 (a secretogranin II-derived peptide) that allowed us to demonstrate that (i) plasma concentrations of the peptide are significantly elevated in pheochromocytoma patients, (ii) combined with other biological tests EM66 measurement increase the diagnostic sensitivity for these neoplasms, (iii) after surgical removal of the tumor, plasma EM66 concentrations rapidly return to basal level and, (iv) intra-tumoral EM66 concentrations are higher in benign than in malignant pheochromocytomas (Yon et al., 2003, Guillemot et al., 2006). These results reveal that EM66 constitutes a novel tool for the diagnosis, prognosis and follow-up of pheochromocytoma. In the frame of a clinical use of an EM66 measurement test, it is necessary to evaluate the specificity of this marker. For instance, renal deficiency, hypergastrinemia, reduction of renal clearance, type A gastritis, Crohns disease, or proton-pump inhibitory treatment, lead to increase plasma chromogranin A (CgA) concentrations (false-positive cases). In addition, while hypertension account for one of the symptoms of pheochromocytoma patients, in essential hypertensive patients, CgA levels are higher than in normotensive individuals. The main objective of our clinical transfer research project consists to study the specificity of the measurement of EM66 as a diagnostic and prognostic marker of pheochromocytoma. This multicentric study will allow us to compare plasma EM66 levels in pheochromocytoma patients with a cohort of essential hypertensive patients. At the same time, in a long-range prospect, due to the lack of malignancy markers for these tumors, we will investigate if plasma or tumor EM66 levels are correlated to the differentiation status of pheochromocytomas, and if the expression level of a set of genes that we identified by a transcriptomic approach developed in the laboratory, is associated with the malignant status of the tumors. The stakes of this transfer research, involving our laboratory and the Center for Clinical Investigations (CIC) of Rouen and Lille, are to provide an easy and simple novel tool to practitioners and anatomo-pathologists for the screening, the evaluation and the follow-up of patients with neuroendocrine tumors.

02

Conditions studied

  • Pheochromocytoma
  • Paraganglioma
  • Essential Hypertension

Keywords

  • pheochromocytoma
  • paraganglioma
  • hypertension
03

In context

Pheochromocytoma

149 studies on the registry are indexed under Pheochromocytoma; 56 are open to participants now.

This study's enrollment of 60 is above the median of 33 across 81 interventional studies indexed under Pheochromocytoma.

Browse Pheochromocytoma studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Other
    patients with pheochromocytoma

    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.

    Other: usual follow up with regular EM66 & Cga levels assessment

  • Other
    Patients with essential hypertension

    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.

    Other: plasma EM66 & CgA levels assessment

Interventions

  • Otherplasma EM66 & CgA levels assessment

    After inclusion checking to eliminate the presence of pheochromocytoma / paraganglioma, a blood sample will be drawn to assess plasma EM66 and CgA levels.

  • Otherusual follow up with regular EM66 & Cga levels assessment

    Patients with pheochromocytoma / paraganglioma will be followed-up as the international standards recommend. Regularly, blood samples will be drawn for the usual assessment of CgA levels and also EM66 (research purpose) levels.

06

What researchers measure

Primary outcomes

  1. Plasma EM66

    Time frame: two years

Secondary outcomes

  1. Plasma Chromogranin A levels

    Time frame: before treatement

07

Study locations

8 sites
  • CIC 9301
    Lille, 59000, France
  • Endocrinology Department
    Lille, 59000, France
  • Inserm U982/EA 4310; Rouen University (DC2N)
    Mont-Saint-Aignan, 76800, France
  • Cardiology Department
    Paris, 75012, France
  • CIC 9304
    Paris, 75012, France
  • Cic-Crb 0204
    Rouen, 76000, France
  • Endocrinology Department
    Rouen, 76000, France
  • Endocrinology Department, Gustave-Roussy Institute
    Villejuif, 94000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01022515
Lead sponsor
University Hospital, Rouen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Dec 1, 2009
Start date
Nov 2008
Primary completion
Apr 13, 2022
Completion
Apr 13, 2022
Last update
Feb 6, 2026

Study contacts

Anne F Cailleux, MD
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion