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Mutations of Glucocorticoid Receptor in Bilateral Adrenal Hyperplasia (MUTA-GR)

Primary Purpose

General Glucocorticoid Resistance

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

blood collection for mutation characterization

About this trial

This is an interventional basic science trial for General Glucocorticoid Resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chu ReimsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patient

Arm Description

Outcomes

Primary Outcome Measures

frequency of mutations

Secondary Outcome Measures

Full Information

NCT ID

NCT02810496

First Posted

June 16, 2016

Last Updated

June 20, 2016

Sponsor

CHU de Reims

1. Study Identification

Unique Protocol Identification Number

NCT02810496

Brief Title

Mutations of Glucocorticoid Receptor in Bilateral Adrenal Hyperplasia

Acronym

MUTA-GR

Official Title

Prevalence of Mutations of Glucocorticoid Receptors in Bilateral Adrenal Hyperplasia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2012 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CHU de Reims

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

General Glucocorticoid Resistance

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patient

Arm Type

Experimental

Intervention Type

Genetic

Intervention Name(s)

blood collection for mutation characterization

Primary Outcome Measure Information:

Title

frequency of mutations

Time Frame

DAY 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brigitte DELEMER

Phone

326788101

bdelemer@chu-reims.fr

Facility Information:

Facility Name

Chu Reims

City

France

State/Province

Reims

ZIP/Postal Code

51092

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Damien JOLLY

Phone

326788472

Ext

djolly@chu-reims.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

31225872

Citation

Vitellius G, Delemer B, Caron P, Chabre O, Bouligand J, Pussard E, Trabado S, Lombes M. Impaired 11beta-Hydroxysteroid Dehydrogenase Type 2 in Glucocorticoid-Resistant Patients. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5205-5216. doi: 10.1210/jc.2019-00800.

Results Reference

derived

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Mutations of Glucocorticoid Receptor in Bilateral Adrenal Hyperplasia

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