NCT06472830

Brief Summary

This study is being done to screen adults for MGUS and to better understand the genetic and immune factors linked to this condition. Monoclonal gammopathy of undetermined significance or MGUS is a condition where an abnormal immune protein is found in the blood. MGUS is not cancer. In some people, it slowly develops into a blood cancer called multiple myeloma. MGUS occurs in people from all backgrounds. Researchers hope to use the information from this study to improve knowledge, early detection, and future care for everyone.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started May 2024

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 Progress39%
May 2024May 2029

Study Start

First participant enrolled

May 22, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

June 19, 2024

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of monoclonal gammopathies across ancestrally diverse populations

    Screen for monoclonal gammopathies using mass spectrometry to detect monoclonal proteins among people across ancestrally diverse populations in Minnesota, with prespecified, ancestry-informed analyses within East African, West African, Afro-Caribbean, and Non-Hispanic White groups.

    Up to 10 years

Study Arms (1)

Observational

Participants undergo medical chart review and blood sample collection, as well as complete a questionnaire on study. Participants who test positive for MGUS are notified, along with their primary care physician, so that the necessary follow up and referral is provided as clinically indicated.

Other: Non-Interventional Study

Interventions

Non-interventional study

Observational

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults attending primary care clinics at Mayo Clinic and Mayo Clinic Health Systems, or health fairs and events

You may qualify if:

  • Adults ≥ 40 years
  • Willing and able to review, understand, and provide consent before starting any study-specific procedures
  • Ability to complete questionnaire(s) by themselves or with assistance

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance

Condition Hierarchy (Ancestors)

HypergammaglobulinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesParaproteinemiasImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Joselle M. Cook, M.B.B.S.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

May 22, 2024

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

May 31, 2029

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations