Exosome-based Omic Signatures of Disease Activity in Card... | NCT07604220

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

NCT07604220

Sponsor

Mayo Clinic

Status

Not yet recruiting

Last Update Posted

May 22, 2026Actual

Enrollment

115Estimated

Phase

Not provided

Conditions

Cardiac Sarcoidosis
Sarcoidosis of the Heart
Sarcoidosis With Myocarditis
Sarcoidosis, Cardiac

Interventions

Exosome Analysis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Jul 2028Estimated

Completion Date

Jul 2028Estimated

First Submitted Date

May 18, 2026

First Submission Date that Met QC Criteria

May 18, 2026

First Posted Date

May 22, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

115Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac Sarcoidosis Patients		Patients with a clinical suspicion or a previously confirmed diagnosis of cardiac sarcoidosis.	Other: Exosome Analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exosome Analysis	Other	Blood Samples will undergo exosome profiling using mass spectrometry and/or other discovery-based approaches	Cardiac Sarcoidosis Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anna Pick	Contact	507-255-0630		pick.anna@mayo.edu

Overall Officials

Name	Affiliation	Role
Andrew Rosenbaum, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012507	Sarcoidosis

Ancestor Terms

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D006968	Hypersensitivity, Delayed

Browse Leaves

Not provided

Browse Branches

Not provided