Exosome-based Omic Signatures of Disease Activity in Cardiac Sarcoidosis (EXODACS) (EXODACS)

May 18, 2026 updated by: Andrew N Rosenbaum, Mayo Clinic
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Rosenbaum, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients referred to the Cardiac Sarcoid Clinic with a clinical suspicion or a previously confirmed diagnosis of cardiac sarcoidosis.

Description

Inclusion Criteria

  • 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.

Exclusion Criteria

• Inability to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac Sarcoidosis Patients
Patients with a clinical suspicion or a previously confirmed diagnosis of cardiac sarcoidosis.
Other: Exosome Analysis
Blood Samples will undergo exosome profiling using mass spectrometry and/or other discovery-based approaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Andrew Rosenbaum, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-004241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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