Cancer Clinical Trial
— NEPHROGENE2Official title:
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Managing patients with renal failure requires an understanding of the molecular mechanisms that lead to its occurrence (i.e. upstream of the disease), its worsening and its persistence (i.e. downstream), while also specifying the risk of worsening renal failure (risk stratification, intolerance to the treatment or complications (infectious, metabolic, cardiovascular, cancer…). Nephrogene 2.0 aims to study these different components of kidney, immune and solid organ transplantation (SOT)-related diseases.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | September 1, 2032 |
Est. primary completion date | September 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Patients (> 18 year of age) with kidney disease or at risk to develop a kidney disease, - Patients followed by a practitioner of the Department of Nephrology and Organ Transplantations of the University Hospital of Toulouse (France) Exclusion Criteria: - consent deny - inability of the patient or its family to give consent. |
Country | Name | City | State |
---|---|---|---|
France | Rangueil University Hospital | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases. | To identify the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases. An unbiased multi-omic approach (including peptidomics, metabolomics, genome sequencing, and flow cytometry and transcriptomic of circulating immune cells) will be performed at the inclusion in the study and correlated to specific end-points (acute kidney injury, kidney failure progression, end-stage kidney disease, infection, cancer according to the underlying condition). Multiple measurements will be studied individually to identify genes variations, gene expression changes, urinary or plasma peptides abundance, immune cells relative abundance in the blood that correlate with the end-point. In a second step, an attempt to combine them in a single predictive signature using artificial intelligence approach. | yearly and up to 10 years after inclusion in the study | |
Secondary | Identification of the predictive factors (immunological, metabolic, genetic…) for the development or progression of renal diseases | To identify the predictive factors (immunological, metabolic, genetic…) for the development or progression of renal diseases: end-points will be end-stage kidney disease, or a decrease of the estimated glomerular filtration rate (eGFR) > 50% | up to 10 years after inclusion in the study | |
Secondary | Identification of the molecular mechanisms (immunological, genetic…) driving complications of kidney, immune and SOT-related diseases | To identify the molecular mechanisms (immunological, genetic…) driving complications of kidney, immune and SOT-related diseases: end-points will the development of bacterial, viral (CytoMégaloVirus, Herpes simplex virus, varicella-zoster virus, BK virus…) or fungal (candidiasis, aspergillosis…) infections, as well as cardiovascular events or other complications | up to 10 years after inclusion in the study | |
Secondary | To specify the individual risk of complications secondary to SOT or its treatment | To specify the individual risk of renal and immunological complications secondary to cancer or hematological malignancies, or their treatments: end points will be the development of acute kidney injury, end-stage kidney disease or >50% reduction of the eGFR | up to 10 years after inclusion in the study |
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