SRDK0921_APS: SRDK0921_ Analytical Performance Study
Study Details
Study Description
Brief Summary
Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
It is a retrospective, observational, non-randomised study using clinical data and samples from DIVAT bio-collection.
The aim of this study is to validate the analytical performance of the SRDK0921 Diagnostic test.
The SRDK0921 system (kit and software) is intended to calculate a score of subclinical rejection in kidney transplant patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| The Divat COHORT The DIVAT cohort (Computerized and Validated Data in Transplantation) developed by the Immunology and Nephrology Department of the University Hospital of Nantes (France) , is a bio-collection database linked to clinical data and plasma, serum, blood cells and urines of all kidney recipients from Nantes, Paris-Necker, and Lyon centres. The clinical and biological parameters are collected at 3 months, 6 months, 1 year and then every year. All available specimens in the DIVAT cohort that: meet inclusion and exclusion criteria of this study AND are usable in terms of quality, integrity, and quantity. will be analysed for this study in order to maximise the power and generalisability of the results. |
Other: No intervention
It is a retrospective study using samples and clinical data from the Divat Cohort
|
Outcome Measures
Primary Outcome Measures
- Area under curve: AUC ≥ 0.75 will be considered as clinically acceptable [at 1 year after kidney transplant]
This model will include the signature expression of two genes of interest and the four clinical parameters determined in the Proof-Of-Concept study. The AUC of the ROC (receiver operating characteristic) curve will be determined from the logistic regression model.
Secondary Outcome Measures
- Analytical sensitivity, specificity PPV, NPV, Cut-off-value [at 1 year after kidney transplant]
To determine additional indicators of analytical performance of the medical device. PPV: positive predictive value NPV: negative predictive value
- Quantification of the gene expression signature [at 1 year after kidney transplant]
To assess the correlation level between the prior Proof-of-Concept study and this study based on the 2 genes expression signature.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects that underwent kidney transplant between January 2008 and January 2016 in the following sites: University hospital center of Nantes, AP-HP Paris-Necker, and HCL Lyon.
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Subjects transplanted from living or deceased donors.
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Patients with an available paired frozen mRNA and biopsy collected at one-year post- transplantation and archived in the DIVAT bio-collection.
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Subjects with good kidney function at one-year post-transplantation (creatininemia below 160 µmol. L-1)
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Subjects under standard immunosuppressive treatments.
Exclusion Criteria:
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Subjects that underwent a graft biopsy for medical indication at one-year post- kidney transplantation.
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Subjects that have stopped immunosuppressive treatments.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- BioMAdvanced Diagnostics
Investigators
- Study Director: Nicolas Bouler, BioMAdvanced Diagnostics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SRDK0921_APS