Cardiac SarcoidosisEXODACSNCT07604220
Exosome-based Omic Signatures of Disease Activity in Cardiac Sarcoidosis (EXODACS)
An observational study of Cardiac Sarcoidosis and Sarcoidosis of the Heart, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to develop a prospective cohort of patients with and without cardiac sarcoidosis as well as active and inactive disease to develop a prospective biobank from which exosome analysis of peripheral blood will derive unique biomarkers of disease activity in cardiac sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Sarcoidosis, Sarcoidosis of the Heart, Sarcoidosis With Myocarditis
- What is being tested?
- Exosome Analysis
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2026to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 referred to the Cardiac Sarcoid Clinic with a clinical suspicion or a previously confirmed diagnosis of cardiac sarcoidosis.
Who may be able to join
- Adults ≥18 years.
- Patients referred to the Cardiac Sarcoid Clinic with a clinical suspicion or a previously confirmed diagnosis of cardiac sarcoidosis.
- Undergoing FDG-PET as part of standard care.
- Ability to provide informed consent.
Who cannot join
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Anna Pick, 507-255-0630, pick.anna@mayo.edu
Andrew Rosenbaum, MD, (507) 284-0783, Rosenbaum.Andrew@mayo.edu
About this study
The purpose of this study is to develop a prospective cohort of patients with and without cardiac sarcoidosis as well as active and inactive disease to develop a prospective biobank from which exosome analysis of peripheral blood will derive unique biomarkers of disease activity in cardiac sarcoidosis.
- Conditions
- Cardiac Sarcoidosis, Sarcoidosis of the Heart, Sarcoidosis With Myocarditis, Sarcoidosis, Cardiac
- Being tested
- Exosome Analysis
- Keywords
- cardiac sarcoidosis, FDG-PET, disease activity, proteomics
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosome AnalysisOther
Blood Samples will undergo exosome profiling using mass spectrometry and/or other discovery-based approaches
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Sarcoidosis Patients | Patients with a clinical suspicion or a previously confirmed diagnosis of cardiac sarcoidosis. Receives: Other: Exosome Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful biomarker validations
Biomarker validation will be defined as ability to discriminate active from inactive or quiescent disease as assessed by FDG-PET
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start13 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew N Rosenbaum, Mayo Clinic
- Investigators
- Andrew Rosenbaum, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604220
- Sponsor's protocol ID
- 26-004241
- Acronym
- EXODACS
- Status last verified
- Aug 2026
- First submitted
- 18 May 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosome-based Omic Signatures of Disease Activity in Cardiac Sarcoidosis (EXODACS)
- ClinicalTrials.gov ID
- NCT07604220
- Acronym / sponsor ID
- EXODACS / 26-004241
- Conditions
- Cardiac Sarcoidosis, Sarcoidosis of the Heart, Sarcoidosis With Myocarditis, Sarcoidosis, Cardiac
- Keywords
- cardiac sarcoidosis, FDG-PET, disease activity, proteomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 May 2026 (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.
The purpose of this study is to develop a prospective cohort of patients with and without cardiac sarcoidosis as well as active and inactive disease to develop a prospective biobank from which exosome analysis of peripheral blood will derive unique biomarkers of disease activity in cardiac sarcoidosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Sarcoidosis Patients | – | Other: Exosome AnalysisPatients with a clinical suspicion or a previously confirmed diagnosis of cardiac sarcoidosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the Cardiac Sarcoid Clinic with a clinical suspicion or a previously confirmed diagnosis of cardiac sarcoidosis.
Key inclusion criteria (4 listed)
- Adults ≥18 years.
- Patients referred to the Cardiac Sarcoid Clinic with a clinical suspicion or a previously confirmed diagnosis of cardiac sarcoidosis.
- Undergoing FDG-PET as part of standard care.
- Ability to provide informed consent.
Key exclusion criteria (1 listed)
- Inability to provide 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exosome AnalysisBlood Samples will undergo exosome profiling using mass spectrometry and/or other discovery-based approaches | Other | Cardiac Sarcoidosis Patients |
Primary outcome
Number of successful biomarker validations
Time frame: Baseline
Biomarker validation will be defined as ability to discriminate active from inactive or quiescent disease as assessed by FDG-PET
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Andrew Rosenbaum, MD principal investigator
Mayo Clinic
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 Cardiac Sarcoidosis and Sarcoidosis of the Heart, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Pick (507-255-0630, pick.anna@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful biomarker validations (time frame: Baseline). 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 17 Aug 2026.