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

Primary Purpose

Acute Kidney Injury, Renal Calculi, Percutaneous Nephrolithotomy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Percutaneous nephrolithotomy
Extracorporeal Shock Wave Lithotripsy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Kidney Injury focused on measuring lncRNA, mRNA, ESWL,PCNL,SBF2-AS1, FENDRR-19, NLRP3.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Urology Department, Faculty of Medicine, Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Percutaneous nephrolithotomy

Extracorporeal Shock Wave Lithotripsy

control group

Arm Description

patients suffering of pelvic renal stones underwent Percutaneous nephrolithotomy

patients suffering of pelvic renal stones underwent Extracorporeal Shock Wave Lithotripsy

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 31, 2021
Last Updated
February 18, 2022
Sponsor
Ain Shams University
Collaborators
Science,Technology & Innovation Funding Authority
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1. Study Identification

Unique Protocol Identification Number
NCT05077007
Brief Title
Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers
Official Title
Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 22, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
Collaborators
Science,Technology & Innovation Funding Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Renal Calculi, Percutaneous Nephrolithotomy, Extracorporeal Shockwave Lithotripsy
Keywords
lncRNA, mRNA, ESWL,PCNL,SBF2-AS1, FENDRR-19, NLRP3.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous nephrolithotomy
Arm Type
Active Comparator
Arm Description
patients suffering of pelvic renal stones underwent Percutaneous nephrolithotomy
Arm Title
Extracorporeal Shock Wave Lithotripsy
Arm Type
Active Comparator
Arm Description
patients suffering of pelvic renal stones underwent Extracorporeal Shock Wave Lithotripsy
Arm Title
control group
Arm Type
No Intervention
Arm Description
Healthy volunteers with negative history of renal stones or renal impairment to measure the level of urinary markers in their urine samples
Intervention Type
Procedure
Intervention Name(s)
Percutaneous nephrolithotomy
Other Intervention Name(s)
PCNL
Intervention Description
Endoscopic stone Extraction from the kidney by making a puncture and dilate a tract direct into the kidney through muscle wall and renal parenchyma
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Shock Wave Lithotripsy
Other Intervention Name(s)
ESWL
Intervention Description
Using Shock waves from outside the body targeted at a kidney stone causing the stone to fragment. The stones are broken into tiny pieces.
Primary Outcome Measure Information:
Title
Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers
Description
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
Time Frame
Before the procedure by 2hours and after the procedure by 2 and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
waleed Mousa, MD
Phone
+201067628771
Email
waleedmousa2@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Tawfick, MD
Phone
+201223112243
Email
murmer_urology26@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
waleed Mousa
Organizational Affiliation
Urology Department, Ain Shams University, Abassia, Cairo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology Department, Faculty of Medicine, Ain Shams University
City
Cairo
ZIP/Postal Code
11884
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
waleed Mousa, MD
Phone
01067628771
Email
waleedmousa2@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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