- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05298904
Pro-active Genetic Testing in Kidney Transplant Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic Arizona
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Post transplant Kidney and Kidney Pancreas recipients.
Exclusion Criteria:
- Simultaneous Liver Kidney Transplant.
- Simultaneous Heart Kidney Transplant.
- Non renal transplant history.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Kidney Transplants
Kidney transplant patients who are within one-year post transplant.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Genetic mutations of cancer
Time Frame: 1 year
|
Number of subjects to have genetic mutations of cancer in kidney transplant patients receiving care at Mayo Clinic Arizona
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Develop a Biorepository
Time Frame: 1 year
|
Create a biorepository based on whole exome sequencing and clinical data for future analysis
|
1 year
|
|
The impact of genetic testing
Time Frame: 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. |
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Genetic mutations of cardiomyopathy
Time Frame: 1 year
|
Prevalence of genetic mutations for cardiomyopathies in kidney transplant recipients
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Girish Mour, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 21-009697
- NCI-2022-02382 (Registry Identifier: CTRP (Clinical Trials Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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