NCT01022515

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2022

Completed
Last Updated

February 6, 2026

Status Verified

June 1, 2014

Enrollment Period

13.5 years

First QC Date

November 17, 2009

Last Update Submit

February 4, 2026

Conditions

PheochromocytomaParagangliomaEssential Hypertension

Keywords

pheochromocytomaparagangliomahypertension

Outcome Measures

Primary Outcomes (1)

  • Plasma EM66

    two years

Secondary Outcomes (1)

  • Plasma Chromogranin A levels

    before treatement

Study Arms (2)

patients with pheochromocytoma

OTHER

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

Patients with essential hypertension

OTHER

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

usual follow up with regular EM66 & Cga levels assessmentOTHER

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.

patients with pheochromocytoma
plasma EM66 & CgA levels assessmentOTHER

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

Patients with essential hypertension

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men \& women, age \> 18 years old
  • Patients informed and willing to participate in the study
  • Patients newly diagnosed, recently operated and the histological findings disprove pheochromocytoma or paraganglioma.
  • patient imprisoned or under legal protection.
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CIC 9301

Lille, 59000, France

Location

Endocrinology Department

Lille, 59000, France

Location

Inserm U982/EA 4310; Rouen University (DC2N)

Mont-Saint-Aignan, 76800, France

Location

Cardiology Department

Paris, 75012, France

Location

CIC 9304

Paris, 75012, France

Location

Cic-Crb 0204

Rouen, 76000, France

Location

Endocrinology Department

Rouen, 76000, France

Location

Endocrinology Department, Gustave-Roussy Institute

Villejuif, 94000, France

Location

MeSH Terms

Conditions

PheochromocytomaParagangliomaEssential HypertensionHypertension

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueVascular DiseasesCardiovascular Diseases

Study Officials

  • Anne F Cailleux, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2009

First Posted

December 1, 2009

Study Start

November 1, 2008

Primary Completion

April 13, 2022

Study Completion

April 13, 2022

Last Updated

February 6, 2026

Record last verified: 2014-06

Locations

FR(8)