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

February 18, 2022 updated by: Ain Shams University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11884
        • Recruiting
        • Urology Department, Faculty of Medicine, Ain Shams University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers
Time Frame: 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
Before the procedure by 2hours and after the procedure by 2 and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Science,Technology & Innovation Funding Authority

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

August 22, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 77/ 2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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