NCT04462068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

January 25, 2024

Status Verified

May 1, 2023

Enrollment Period

4 years

First QC Date

May 11, 2020

Last Update Submit

January 24, 2024

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

  • Time to initiation of treatment

    Time to initiation of systemic immunosuppression for sarcoidosis

    1 year from diagnosis

Secondary Outcomes (4)

  • Number of participants with extrapulmonary organ involvement

    1 year from diagnosis

  • Change in FEV1

    1 year

  • Change in FVC

    1 year

  • Change in diffusion capacity

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with sarcoidosis seen in Department of Respiratory Diseases, Aarhus Denmark

You may qualify if:

  • Diagnosis of sarcoidosis
  • Signed informed consent

You may not qualify if:

  • Inability or unwillingness to adhere to the study
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology

Aarhus N, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2020

First Posted

July 8, 2020

Study Start

December 1, 2019

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

January 25, 2024

Record last verified: 2023-05

Locations

DK(1)