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NCT05298904 Clinical Trial

Pro-active Genetic Testing in Kidney Transplant Patients

Kidney Transplant Clinical Trial

Official title:
Pro-active Genetic Testing in Kidney Transplant Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05298904
Other study ID # 21-009697
Secondary ID NCI-2022-02382
Status Active, not recruiting
Phase
First received
Last updated
Start date March 28, 2022
Est. completion date March 1, 2038

Study information
Verified date February 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 177
Est. completion date March 1, 2038
Est. primary completion date March 1, 2037
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Post transplant Kidney and Kidney Pancreas recipients. Exclusion Criteria: - Simultaneous Liver Kidney Transplant. - Simultaneous Heart Kidney Transplant. - Non renal transplant history.

Study Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
United States Mayo Clinic Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Genetic mutations of cardiomyopathy Prevalence of genetic mutations for cardiomyopathies in kidney transplant recipients 1 year
Primary 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 The impact of genetic testing 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.		 1 Year
Secondary Develop a Biorepository Create a biorepository based on whole exome sequencing and clinical data for future analysis 1 year
See also
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