Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing's Syndrome

NCT03211624 | Active Not Recruiting

• 1 other identifier: CognCush
• Study Type: observational
• Target: 72
• Locations: 3 countries
• Sites: 3

Brief Summary

This is a prospective, multi-center, case-control study where neurocognitive function will be evaluated in 36 patients with Cushing syndrome (CS) and 36 controls matched for age, gender and education.

Conditions

Cushing Syndrome

Outcome Measures

Primary Outcomes (1)

• Cognitive function

  Improvement in memory 2 years after treatment of Cushing syndrome evaluated with the Rey Complex Figure.

  2 years

Secondary Outcomes (5)

• Test score in CushingQoL test

  2 years

• Brain volume

  2 years

• Functional brain response

  2 years

• Glucose utilization

  2 years

• Polymorphisms in the GC receptor gene or genes involved in metabolism and transport of GCs

  2 years

Study Arms (2)

Cushing syndrome

Male and female patients with Cushing syndrome caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma

Controls

Healthy controls matched for age, gender, and educational level

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Thirty-six patients with newly diagnosed endogenous Cushing syndrome and 36 matched controls

You may qualify if:

• Male and female patients with Cushing syndrome (CS) caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma
• Age between 18 and 65 years

You may not qualify if:

• CS caused by ectopic ACTH producing tumours
• CS caused by adrenocortical carcinoma
• Pseudo CS
• Subclinical CS
• Exogenous CS
• Previous history of major psychiatric disorder (not related to CS)
• Neurological disorders affecting the central nervous system
• High alcohol consumption (more than 14 units of alcohol per week)
• Active malignancy or any treatment for malignancy during the last 2 years
• Heart failure (NYHC II-IV)
• Severe respiratory insufficiency
• Severely impaired hepatic function (alanine transaminase and/or aspartate transaminase concentrations two times the upper limit of normal or above)
• Severely impaired renal function (serum- creatinine \>150 µmol/L or glomerular filtration rate \<45 ml/min)
• Pregnancy or breast feeding
• Any other illness that significantly affects the patients cognitive function according to the investigators opinion

Sponsors & Collaborators

• Göteborg University: lead
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Leiden University Medical Center: collaborator

Study Sites (3)

Dept of Medicine, Division of Endocrinology, and Center for Endocrine Tumors, Leiden University Medical Center

Leiden, Netherlands

Location

Dept of Endocrinology, Hospital Sant Pau

Barcelona, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

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.

MeSH Terms

Conditions

Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Oskar Ragnarsson, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: July 7, 2017
• Study Start: May 1, 2017
• Primary Completion: April 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

SE (1); NL (1); ES (1)