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

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ClinicalTrials.gov Identifier: NCT02810496
Recruitment Status : Unknown
Verified June 2016 by CHU de Reims.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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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.

Condition or disease Intervention/treatment Phase
General Glucocorticoid Resistance Genetic: blood collection for mutation characterization Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Prevalence of Mutations of Glucocorticoid Receptors in Bilateral Adrenal Hyperplasia
Study Start Date : April 2012
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arms and Interventions
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Arm Intervention/treatment
Experimental: patient Genetic: blood collection for mutation characterization


Outcome Measures
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Primary Outcome Measures :
  1. frequency of mutations [ Time Frame: DAY 0 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810496


Contacts
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Contact: Brigitte DELEMER 326788101 bdelemer@chu-reims.fr

Locations
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France
Chu Reims Recruiting
France, Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02810496    
Other Study ID Numbers: PN11010
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Hyperplasia
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
 Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs