NCT06456320

Brief Summary

The purpose of this study is to use multi-omics testing on samples collected from Mayo Clinic patients to build and expand on what has been learned about genomic data.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

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

Study Progress50%
Sep 2024Dec 2027

First Submitted

Initial submission to the registry

June 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 5, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

October 16, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

June 7, 2024

Last Update Submit

October 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Creation of a unique integrated asset of multi-omics data

    A variety of patient cohorts will be ascertained throughout this study. Data will be made available to researchers to query correlations of disease states and clinical outcomes to multi-omics findings. These insights will be invaluable to creating omics-informed care plans in the future. Standard descriptive statistics approaches will be used for analysis.

    Up to 5 years

Study Arms (2)

Suspected Genetic Predisposition or Multi-Omics Contribution

Patients with a diagnosis or phenotype with the potential for association with a genetic predisposition or Multi-Omics Contribution.

Healthy Control

Patients with no diagnosis associated with a genetic predisposition or Multi-Omics Contribution.

Eligibility Criteria

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

Mayo Clinic patients

You may qualify if:

  • Age ≥ 18 years
  • Registered Mayo Clinic patient
  • Able to provide informed written consent
  • Able to receive mail and packages within a United States (US) state
  • Able to collect and ship samples within a US state

You may not qualify if:

  • Active hematological cancer or history of a hematological cancer
  • Allogeneic Bone Marrow Transplant (e.g., samples from autologous bone marrow transplant recipients are acceptable if collected at least one month after transplant)
  • Other co-morbidity that, in physician's opinion, would interfere with patient's ability to participate in the study (e.g., reduced ability to comprehend, i.e., dementia, intellectual disability, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool, urine, saliva, plasma, white blood cells (WBC), peripheral blood mononuclear cells (PBMC), whole blood

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Konstantinos N. Lazaridis, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director, Center for Individualized Medicine

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 13, 2024

Study Start

September 5, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

October 16, 2025

Record last verified: 2025-09

Locations