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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05425953
Other study ID # EMKI SCA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 13, 2022
Est. completion date May 1, 2025

Study information

Verified date November 2023
Source University of Aarhus
Contact Lukas O Ridder, MD
Phone 25337447
Email Lukrid@clin.au.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observational study of 160 patients with sex-chromosome abnormalities and 160 matched controls. Blood, fat, muscle, skin, buccal swaps, urine will be collected and analyzed for DNA, RNA and methylation patterns. The goal is to associated genotype and epigenetic changes with the phenotype of patients with sex-chromosome abnormalities. Patients participate in questionaries, dexa-scan of bones, fibroscan of liver, ultra sound of testicles and blood will be analyzed for organ specific blood work as well as immunological and coagulation components.


Description:

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Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date May 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Participants must have the sex-chromosome abnormality Exclusion Criteria: -

Study Design


Intervention

Other:
No intervention other than obtaining biopsies
Biopsies will be obtained.

Locations

Country Name City State
Denmark Aarhus university hospital Aarhus Region Midt

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

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Outcome

Type Measure Description Time frame Safety issue
Primary Epigenetic changes relate to phenotype Epigenetic changes relate to phenotype 2½ years
Secondary Immunologic changes in turner syndrom Patients with Turner syndrome may have altered immunological properties 2 years
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