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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02810496
Other study ID # PN11010
Secondary ID
Status Recruiting
Phase N/A
First received June 16, 2016
Last updated June 20, 2016
Start date April 2012

Study information

Verified date June 2016
Source CHU de Reims
Contact Brigitte DELEMER
Phone 326788101
Email bdelemer@chu-reims.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

As the investigators observed a case of glucocorticoid mutation revealed by incidentally discovered bilateral adrenal nodular hyperplasia, it was postulated that this molecular anormality could be more frequent than previously described. To validate this hypothesis, it was decided to study 150 multicenter consecutive patients, presenting with incidentally discovered bilateral adrenal masses without clinical signs of Cushing's disease. In all these patients GR gene will be studied, mutations will be detected and described, functional disturbance will be tested. Usual polymorphisms will be described. Correlation between clinical signs, hormonal and morphological abnormalities and presence or absence of GR mutations will be searched.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients more than 18 years of age

- patients with bilateral adrenal masses

Exclusion Criteria:

- Refusing to participate in the study

- Protected by law

- Have obvious signs of Cushing's syndrome

- No progressive neoplastic disease

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Genetic:
blood collection for mutation characterization


Locations

Country Name City State
France Chu Reims France Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary frequency of mutations DAY 0 No