Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing's Syndrome
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|ClinicalTrials.gov Identifier: NCT03211624|
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : November 6, 2018
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||72 participants|
|Official Title:||The Etiology and Extent of Impaired Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing's Syndrome - Prospective Studies|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2023|
Male and female patients with Cushing syndrome caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma
Healthy controls matched for age, gender, and educational level
- Cognitive function [ Time Frame: 2 years ]Improvement in memory 2 years after treatment of Cushing syndrome evaluated with the Rey Complex Figure.
- Quality of life [ Time Frame: 2 years ]Improvement in quality of life 2 years after treatment of Cushing syndrome, measured with the CushingQoL
- Brain volume [ Time Frame: 2 years ]Changes in total brain volume and volume of structures important for cognitive function such as hippocampus and frontal cortex 2 years after treatment of Cushing syndrome by using structural MRI
- Functional brain response [ Time Frame: 2 years ]Changes in brain functional connectivity during rest and during testing of cognitive and emotional functioning 2 years after treatment of Cushing syndrome by using functional MRI
- Glucose utilization [ Time Frame: 2 years ]Change in glucose utilization in the hippocampus and frontal cortex 2 years after treatment of Cushing syndrome by using Fludeoxyglucose Positron emission tomography (FDG-PET).
- Genetic analysis. [ Time Frame: 2 years ]To evaluate the influence of polymorphisms in the GC receptor gene, and genes involved in metabolism and transport of GCs, on memory and attention in patients with CS.
Biospecimen Retention: Samples With DNA
Blood samples for DNA and RNA isolation will be collected and stored at −80°C.
Polymorphism in the glucocorticoid (GC) receptor gene, and other genes involved in metabolism and transport of GCs will be analysed in all subjects at inclusion in the study.
DNA methylation and mRNA will be analyzed at inclusion and 24 months after treatment.
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): NCT03211624
|Contact: Oskar Ragnarsson, MD, PhDemail@example.com|
|Dept of Medicine, Division of Endocrinology, and Center for Endocrine Tumors, Leiden University Medical Center||Enrolling by invitation|
|Dept of Endocrinology, Hospital Sant Pau||Recruiting|
|Contact: Susan Webb, MD, PhD SWebb@santpau.cat|
|Sahlgrenska University Hospital||Enrolling by invitation|
|Gothenburg, Sweden, 41345|
|Principal Investigator:||Oskar Ragnarsson, MD, PhD||Sahlgrenska University Hospital, Sweden|