Pro-active Genetic Testing in Kidney Transplant Patients

Active, not recruiting

• Conditions: Kidney Transplant
• Interventions: Diagnostic Test: Genetic Health Screen Panel

• Registration Number: NCT05298904
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-25
• Study Start: 2022-03-28
• Study First Posted: 2022-03-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-18
• Primary Completion: 2037-03-01
• Study Completion: 2038-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• Post transplant Kidney and Kidney Pancreas recipients.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney Transplants	Genetic Health Screen Panel	Kidney transplant patients who are within one-year post transplant.

Primary Outcome Measures

Name	Time	Method
Genetic mutations of cancer	1 year	Number of subjects to have genetic mutations of cancer in kidney transplant patients receiving care at Mayo Clinic Arizona

Secondary Outcome Measures

Name	Time	Method
The impact of genetic testing	1 Year	Current guidelines for cancer screening have limitations, as its mostly age based. Immunosuppression can lead to a increased risk of cancer in the kidney transplant population.; By utilizing a multi gene panel we'll look for the number subjects with positive findings and see how recommendations of care change vs standard of care as recommended by the National Comprehensive Cancer Network (NCCN). Genetic testing and family history may change the practice regarding cancer screening in subjects undergoing kidney transplant evaluation.
Develop a Biorepository	1 year	Create a biorepository based on whole exome sequencing and clinical data for future analysis

Trial Locations

Locations (1)

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States