| CTRI Number |
CTRI/2026/04/108655 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
19/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Urine Test (MMP-7) to Guide Surgery and Monitor Treatment in children with Ureteropelvic Junction (UPJ) Obstruction” |
|
Scientific Title of Study
|
Evaluation of potential of urinary Matrix Metalloproteinase-7 (MMP-7) as a biomarker for decision making of pyeloplasty and therapeutic monitoring in patients with unilateral uretero-pelvic junction obstruction. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Divya Tomar |
| Designation |
Senior |
| Affiliation |
Maulana Azad Medical College |
| Address |
Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
8474907254 |
| Fax |
|
| Email |
divyatomar428@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Chiranjiv Kumar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
8700931263 |
| Fax |
|
| Email |
divyatomar428@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Divya Tomar |
| Designation |
Senior Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
8474907254 |
| Fax |
|
| Email |
divyatomar428@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lok Nayak Hospital and associated Maulana Azad Medical College |
| Address |
Maulana Azad Medical College |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya Tomar |
Maulana Azad Medical College |
Paediatric Surgery Department, 5th floor, Lok Nayak Hospital
New Delhi
DELHI |
8474907254
divyatomar428@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children up to 12 years of age with unilateral HDN |
|
| ExclusionCriteria |
| Details |
i)Solitary kidney.
ii)Bilateral HDN.
iii)Syndromic patients
iv)Patients having secondary UPJO, e.g., due to urolithiasis, vesicoureteric reflux (VUR)
v)Patients with history of previous surgery on kidneys.
vi)Other medical renal disease, causing raised urine and serum MMP-7 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the association between urinary MMP-7 levels and ultrasonographic parameters, specifically the pelvis-to-cortex ratio and SFU grading, in children with UPJO.
2.To evaluate the association between urinary MMP-7 levels and split renal function (SRF) obtained on renal dynamic scans. |
baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the optimal urinary MMP-7 cut-off value for predicting the need for surgical intervention in children with UPJO using Receiver Operating Characteristic (ROC) curve analysis.
2.To validate urinary MMP-7 as a biomarker by assessing the correlation between baseline urinary MMP-7 (absolute & creatinine-normalized values) & serum MMP-7 levels, thereby determining whether urinary concentrations reflect systemic levels in UPJO.
3.To evaluate follow-up changes in urinary MMP-7 levels (absolute & creatinine-normalized) at 3 months post-surgery & determine their relationship with postoperative improvement in imaging parameters, including pelvis-cortex ratio, SFU grade, & split renal function. |
baseline & 3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ureteropelvic junction obstruction is a major cause of hydronephrosis in children and can result in progressive renal damage. While some patients improve with observation, others require pyeloplasty. Renal dynamic scan is the current standard for assessing obstruction and split renal function but has limitations such as radiation exposure and occasional inconclusive results. Hence a reliable non invasive biomarker is needed. Matrix metalloproteinase 7 is associated with renal injury and fibrosis and may reflect the severity of obstruction. This prospective study will evaluate urinary MMP 7 in children up to 12 years with unilateral UPJO and correlate it with pelvis to cortex ratio, Society for Fetal Urology grade, and split renal function. Levels will be assessed before surgery and three months after intervention. The study will also determine a cut off value for predicting surgical need and compare urinary with serum MMP 7. The findings may support the role of urinary MMP 7 in decision making and postoperative monitoring in UPJO. |