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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05077007
Collaborator
Science,Technology & Innovation Funding Authority (Other)
75
Enrollment
1
Location
3
Arms
22
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous nephrolithotomy
  • Procedure: Extracorporeal Shock Wave Lithotripsy
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Aug 22, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Percutaneous nephrolithotomy

patients suffering of pelvic renal stones underwent Percutaneous nephrolithotomy

Procedure: Percutaneous nephrolithotomy
Endoscopic stone Extraction from the kidney by making a puncture and dilate a tract direct into the kidney through muscle wall and renal parenchyma
Other Names:
  • PCNL

    		•
    Active Comparator: Extracorporeal Shock Wave Lithotripsy

    patients suffering of pelvic renal stones underwent Extracorporeal Shock Wave Lithotripsy

    Procedure: Extracorporeal Shock Wave Lithotripsy
    Using Shock waves from outside the body targeted at a kidney stone causing the stone to fragment. The stones are broken into tiny pieces.
    Other Names:
  • ESWL

    		•
    No Intervention: control group

    Healthy volunteers with negative history of renal stones or renal impairment to measure the level of urinary markers in their urine samples

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers [Before the procedure by 2hours and after the procedure by 2 and 24 hours]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Inclusion criteria for patients :

    1. Patients undergoing treatment for a stone(s) located in the kidney less than 2 cm

    2. Radiopaque stone

    3. Able and willing to give informed consent

    Inclusion criteria for Healthy volunteers

    1. No history of kidney or stone disease

    2. Asymptomatic

    3. No indwelling ureteral stent

    4. Willing to provide medical history information

    5. Able and willing to give informed consent

    Exclusion Criteria:
    • Exclusion criteria for patients

    1. Active urinary tract infection

    2. Bleeding disorder

    3. Chronic renal failure (eGFR<30)

    4. Ureteral stone

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology Department, Faculty of Medicine, Ain Shams University Cairo Egypt 11884

    Sponsors and Collaborators

    • Ain Shams University
    • Science,Technology & Innovation Funding Authority

    Investigators

    • Principal Investigator: waleed Mousa, Urology Department, Ain Shams University, Abassia, Cairo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05077007
    Other Study ID Numbers:
    • FMASU R 77/ 2021
    First Posted:
    Oct 13, 2021
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ain Shams University
    lncRNA, mRNA, ESWL,PCNL,SBF2-AS1, FENDRR-19, NLRP3.
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Kidney Calculi
    Nephrolithiasis
    Calculi

    Study Results

    No Results Posted as of Feb 22, 2022