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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
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
June 16, 2016
Last Updated
June 20, 2016
Sponsor
CHU de Reims
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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
No
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
Email
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
33
Email
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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