ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients

Sarcoidosis Clinical Trial

Official title:

ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04462068
• Other study ID #: SAR3
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sarcoidosis is a multisystem granulomatous disease of unknown cause histologically characterized by noncaseating granulomas. Genetic factors affect disease course, which is highly variable and difficult to predict.

This study aims to evaluate the predictive value of ACE and HLA genotypes on disease severity and progression in Danish patients with sarcoidosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of sarcoidosis

• Signed informed consent

Exclusion Criteria:

• Inability or unwillingness to adhere to the study

• Inability to give informed consent

Related Conditions & MeSH terms

• Disease Progression
• Sarcoidosis

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to initiation of treatment	Time to initiation of systemic immunosuppression for sarcoidosis	1 year from diagnosis
Secondary	Number of participants with extrapulmonary organ involvement	Number of participants diagnosed with extrapulmonary organ involvement	1 year from diagnosis
Secondary	Change in FEV1	Increase/ decline/ no change in FEV1	1 year
Secondary	Change in FVC	Increase/ decline/ no change in FVC	1 year
Secondary	Change in diffusion capacity	Increase/ decline/ no change in diffusion capacity	1 year