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

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04462068
Collaborator
(none)
150
Enrollment
1
Location
48
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients
    Actual Study Start Date :
    Dec 1, 2019
    Anticipated Primary Completion Date :
    Nov 30, 2023
    Anticipated Study Completion Date :
    Nov 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Time to initiation of treatment [1 year from diagnosis]

      Time to initiation of systemic immunosuppression for sarcoidosis

    Secondary Outcome Measures

    1. Number of participants with extrapulmonary organ involvement [1 year from diagnosis]

      Number of participants diagnosed with extrapulmonary organ involvement

    2. Change in FEV1 [1 year]

      Increase/ decline/ no change in FEV1

    3. Change in FVC [1 year]

      Increase/ decline/ no change in FVC

    4. Change in diffusion capacity [1 year]

      Increase/ decline/ no change in diffusion capacity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of sarcoidosis

    • Signed informed consent

    Exclusion Criteria:

    • Inability or unwillingness to adhere to the study

    • Inability to give informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology Aarhus N Denmark 8200

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT04462068
    Other Study ID Numbers:
    • SAR3
    First Posted:
    Jul 8, 2020
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sarcoidosis
    Disease Progression

    Study Results

    No Results Posted as of Sep 29, 2021