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
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
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
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
NCT ID
NCT05077007
First Posted
August 31, 2021
Last Updated
February 18, 2022
Sponsor
Ain Shams University
Collaborators
Science,Technology & Innovation Funding Authority
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
We'll reach out to this number within 24 hrs