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

N/ACompletedNCT04581278

Nantes University Hospital210 enrolled

Overview

Study Type

OBSERVATIONAL

Enrollment

210

Conditions

Kidney Transplant

Interventions

KTD Innov-2DIAGNOSTIC_TEST

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.

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 12 months

Secondary Outcomes

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

Time frame: 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

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes