NCT05298904

Brief Summary

The purpose of this study is to determine the prevalence of genetic mutations that increase the risk of cancer and other medically actionable diseases in kidney transplant patients and to assess the impact of genetic testing on subsequent surveillance for cancer.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
144mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress26%
Mar 2022Mar 2038

First Submitted

Initial submission to the registry

March 11, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 28, 2022

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2037

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2038

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

14.9 years

First QC Date

March 11, 2022

Last Update Submit

January 25, 2026

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

  • Genetic mutations of cancer

    Number of subjects to have genetic mutations of cancer in kidney transplant patients receiving care at Mayo Clinic Arizona

    1 year

Secondary Outcomes (2)

  • The impact of genetic testing

    1 year

  • Develop a Biorepository

    1 year

Other Outcomes (1)

  • Genetic mutations of cardiomyopathy

    1 year

Study Arms (1)

Kidney Transplants

Kidney transplant patients who are within one-year post transplant.

Diagnostic Test: Genetic Health Screen Panel

Interventions

Genetic Health Screen PanelDIAGNOSTIC_TEST

This panel covers cardiomyopathy genes, and cancer genes. The results of this panel are reported as Positive (pathogenic or likely pathogenic mutation identified in one or more genes) or Negative (no pathogenic/likely pathogenic mutations identified).

Kidney Transplants

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be identified internally to Mayo Clinic Arizona via the kidney transplant program within one-year post transplant.

You may qualify if:

  • \- Post transplant Kidney and Kidney Pancreas recipients.

You may not qualify if:

  • Simultaneous Liver Kidney Transplant.
  • Simultaneous Heart Kidney Transplant.
  • Non renal transplant history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Participants will be asked to provide a blood sample. Participants may be asked to provide an additional research blood sample for biobanking purposes, up to 40mL of blood per subject .

Study Officials

  • Girish Mour, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

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

March 11, 2022

First Posted

March 28, 2022

Study Start

March 28, 2022

Primary Completion (Estimated)

March 1, 2037

Study Completion (Estimated)

March 1, 2038

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)