NCT07604220

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Cardiac SarcoidosisSarcoidosis of the HeartSarcoidosis With MyocarditisSarcoidosis, Cardiac

Keywords

cardiac sarcoidosisFDG-PETdisease activityproteomics

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Study Arms (1)

Cardiac Sarcoidosis Patients

Patients with a clinical suspicion or a previously confirmed diagnosis of cardiac sarcoidosis.

Other: Exosome Analysis

Interventions

Exosome AnalysisOTHER

Blood Samples will undergo exosome profiling using mass spectrometry and/or other discovery-based approaches

Cardiac Sarcoidosis Patients

Eligibility Criteria

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

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

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Andrew Rosenbaum, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Pick

CONTACT

507-255-0630pick.anna@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 22, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)