SarcoidosisNCT04462068
ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients
An observational study of Sarcoidosis, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2019to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sarcoidosis seen in Department of Respiratory Diseases, Aarhus Denmark
Who may be able to join
- Diagnosis of sarcoidosis
- Signed informed consent
Who cannot join
- Inability or unwillingness to adhere to the study
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology
Aarhus N, 8200
About this study
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.
- Conditions
- Sarcoidosis
- Medical subject headings
- Sarcoidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to initiation of treatment
Time to initiation of systemic immunosuppression for sarcoidosis
Measured: 1 year from diagnosis
Secondary outcomes (4)
Number of participants with extrapulmonary organ involvement
Number of participants diagnosed with extrapulmonary organ involvement
Measured: 1 year from diagnosis
Change in FEV1
Increase/ decline/ no change in FEV1
Measured: 1 year
Change in FVC
Increase/ decline/ no change in FVC
Measured: 1 year
Change in diffusion capacity
Increase/ decline/ no change in diffusion capacity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Dec 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462068
- Sponsor's protocol ID
- SAR3
- Status last verified
- May 2023
- First submitted
- 11 May 2020
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients
- ClinicalTrials.gov ID
- NCT04462068
- Acronym / sponsor ID
- SAR3
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sarcoidosis seen in Department of Respiratory Diseases, Aarhus Denmark
Key inclusion criteria (2 listed)
- Diagnosis of sarcoidosis
- Signed informed consent
Key exclusion criteria (2 listed)
- Inability or unwillingness to adhere to the study
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to initiation of treatment
Time frame: 1 year from diagnosis
Time to initiation of systemic immunosuppression for sarcoidosis
4 secondary outcomes
Number of participants with extrapulmonary organ involvement
Time frame: 1 year from diagnosis
Change in FEV1
Time frame: 1 year
Change in FVC
Time frame: 1 year
Change in diffusion capacity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Sarcoidosis
RecruitingPhase 2/3
A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Pulmonary Sarcoidosis
Not yet recruitingPhase 2
LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
Sarcoidosis Associated Pulmonary Hypertension
RecruitingObservational study
Prognostic Value of Clinical Cardiovascular MRI
Sarcoidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to initiation of treatment (time frame: 1 year from diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.