Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers

Study Overview
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Brief Summary
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The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures

Detailed Description
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The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures and assess their usefulness as diagnostic biomarkers for AKI and the relationship between the selected RNA based biomarker panel and clinicopathological changes of patients.

Official Title
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Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers

Conditions
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Acute Kidney Injury, Renal Calculi, Percutaneous Nephrolithotomy, Extracorporeal Shockwave Lithotripsy

Intervention / Treatment
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* Procedure: Percutaneous nephrolithotomy
* Procedure: Extracorporeal Shock Wave Lithotripsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for patients : Patients undergoing treatment for a stone(s) located in the kidney less than 2 cm Radiopaque stone Able and willing to give informed consent Inclusion criteria for Healthy volunteers No history of kidney or stone disease Asymptomatic No indwelling ureteral stent Willing to provide medical history information Able and willing to give informed consent Exclusion Criteria: Exclusion criteria for patients Active urinary tract infection Bleeding disorder Chronic renal failure (eGFR<30) Ureteral stone

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous nephrolithotomy<br>patients suffering of pelvic renal stones underwent Percutaneous nephrolithotomy | Procedure: Percutaneous nephrolithotomy<br>* Endoscopic stone Extraction from the kidney by making a puncture and dilate a tract direct into the kidney through muscle wall and renal parenchyma<br>* Other names: PCNL;|
| Active Comparator: Extracorporeal Shock Wave Lithotripsy<br>patients suffering of pelvic renal stones underwent Extracorporeal Shock Wave Lithotripsy | Procedure: Extracorporeal Shock Wave Lithotripsy<br>* Using Shock waves from outside the body targeted at a kidney stone causing the stone to fragment. The stones are broken into tiny pieces.<br>* Other names: ESWL;|
| No Intervention: control group<br>Healthy volunteers with negative history of renal stones or renal impairment to measure the level of urinary markers in their urine samples | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers | Evaluation of kidney injury after procedures PCNL and ESWL by measuring the change of the level of novel non-coding lnc-RNA profile in urine | Before the procedure by 2hours and after the procedure by 2 and 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lncRNA, mRNA, ESWL,PCNL,SBF2-AS1, FENDRR-19, NLRP3.