Pro-active Genetic Testing in Kidney Transplant Patients

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05298904
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 192
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant	Diagnostic Test: Genetic Health Screen Panel

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pro-active Genetic Testing in Kidney Transplant Patients
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2037
• Anticipated Study Completion Date: Mar 1, 2038

Arms and Interventions

Arm	Intervention/Treatment
Kidney Transplants Kidney transplant patients who are within one-year post transplant.	Diagnostic Test: Genetic Health Screen Panel; 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).

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Develop a Biorepository [1 year]

   Create a biorepository based on whole exome sequencing and clinical data for future analysis

Other Outcome Measures

1. Genetic mutations of cardiomyopathy [1 year]

   Prevalence of genetic mutations for cardiomyopathies in kidney transplant recipients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Post transplant Kidney and Kidney Pancreas recipients.

Exclusion Criteria:

• Simultaneous Liver Kidney Transplant.

• Simultaneous Heart Kidney Transplant.

• Non renal transplant history.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Girish Mour, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Girish K. Mour, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05298904
• Other Study ID Numbers: 21-009697; NCI-2022-02382
• First Posted: Mar 28, 2022
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 28, 2022