NCT07332598

Brief Summary

The goal of this observational study is to 1) better understand and predict biological processes before disease begins or is identified, 2) study genomic and environmental contributors to disease, 3) identify ways to stop disease advancement before it becomes serious or complex, and 4) identify potential targets for disease therapy. Participants will be asked to:

  • collect biological samples,
  • download a mobile app,
  • collect speech (voice) recordings, and
  • complete surveys

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
116mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress3%
Jan 2026Dec 2035

First Submitted

Initial submission to the registry

December 30, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

March 16, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

December 30, 2025

Last Update Submit

March 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Build a comprehensive, multi-omics and phenotype dataset

    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

Health Control

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
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 via FedEx for overnight delivery

You may not qualify if:

  • Active hematological cancer or history of a hematological cancer
  • Allogeneic Bone Marrow Transplant (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 (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

  • Thomas DC. High-volume "-omics" technologies and the future of molecular epidemiology. Epidemiology. 2006 Sep;17(5):490-1. doi: 10.1097/01.ede.0000229950.29674.68. No abstract available.

    PMID: 16906051BACKGROUND
  • Ramos RG, Olden K. Gene-environment interactions in the development of complex disease phenotypes. Int J Environ Res Public Health. 2008 Mar;5(1):4-11. doi: 10.3390/ijerph5010004.

    PMID: 18441400BACKGROUND
  • Wild CP. Complementing the genome with an "exposome": the outstanding challenge of environmental exposure measurement in molecular epidemiology. Cancer Epidemiol Biomarkers Prev. 2005 Aug;14(8):1847-50. doi: 10.1158/1055-9965.EPI-05-0456. No abstract available.

    PMID: 16103423BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, stool, urine, 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

December 30, 2025

First Posted

January 12, 2026

Study Start

January 19, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2035

Last Updated

March 16, 2026

Record last verified: 2026-02

Locations