Validation Study of the Feasibility of an Integrated Diagnostic System of Anatomo-pathological Lesions - Including Rejections - Appearing in Renal Grafts in the First Year of Transplant for Applicability in Routine Clinical Practice : KTD Innov-2 Study

Study Overview
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Brief Summary
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The main objective of the present study (KTD Innov-2) is to validate the feasibility of SDI within a limited time frame to ensure its clinically relevant use, with a high level of evidence to consider its labelling as a medical device by health authorities prior to routine transfer and/or future marketing.

Official Title
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Validation Study of the Feasibility of an Integrated Diagnostic System of Anatomo-pathological Lesions - Including Rejections - Appearing in Renal Grafts in the First Year of Transplant for Applicability in Routine Clinical Practice : KTD Innov-2 Study

Conditions
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Kidney Transplant

Intervention / Treatment
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* Diagnostic Test: KTD Innov-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Male and female patients, age ≥ 18 years at time of transplantation. Patients with a minimum weight of 40 kg in order to allow blood samples to be taken safely in accordance with the table published in the Order of 12 April 2018 setting the list of research mentioned in 3° of Article L. 1121-1 of the Public Health Code. Patients receiving a kidney transplant from a living or brain-dead donor. Patients expressing their non-opposition and ready to comply with the study procedures. Exclusion Criteria : Patients who have received a previous transplant with an organ other than the kidney Patients unable or unwilling to perform study procedures or who do not speak French Vulnerable patients (minors, adults, pregnant women, under guardianship)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: KTD Innov-2|The main objective of the present study (KTD Innov-2) is to validate the feasibility of SDI within a limited time frame to ensure its clinically relevant use, with a high level of evidence to consider its labelling as a medical device by health authorities prior to routine transfer and/or future marketing. 300 kidney transplant patients will be included in the KTD Innov-2 study with data collection, blood, urine and graft biopsies for biomarker analysis and conversion to SDI (decisional algorithms) and interactive multi-dimensional presentation on a web interface for use of the tool by transplant physicians and their patients.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of biological samples necessary for the construction of the SDI | Validation of the circuit for the collection of the blood, urine and biopsy samples | 12 months | 
| Validation of the sample circuit from clinical unit to processing platforms | Path of the biological samples (blood, urine, biopsies) to the sample processing platforms for the editing of the raw results of the blood and urine and biopsy biomarkers | 12 months | 
| Validation of raw results transmission | The transmission of the raw results in the format necessary for the calculation of the diagnostic and/or prognostic algorithms | 12 months | 
| Validation of a final report | Edition of a final numerical report of the algorithms accessible on a web support with an intelligible interpretation by clinicians and patients. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the diagnostic and/or prognostic capabilities of the SDI | The primary secondary endpoints will be to evaluate the sensitivity and specificity, as well as the negative and positive predictive values of the SDI obtained in the KTD innov-1 study, from an incident cohort of 300 new kidney transplant patients meeting the same inclusion criteria as the first KTD innov-1 study | 12 months | 
| Providing a final report of the SDI via web interfaces | The second secondary objective is to validate the integration of the algorithms in the SDI presentation software package | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplant, Integrated Diagnostic System