Prediction of Renal Parenchymal Damage of CAKUT

NCT04537364 | Completed

• 1 other identifier: RPD-CAKUT1
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

To establish the prediction of the renal damage and renal development deficiency in congenital anomalies of kidney and urinary tract (CAKUT), a diagnostic accuracy study on MRI-DWI combined with urinary microprotein detection is to carried out comparing with DMSA scan as the golden standard for renal damage.

Conditions

CAKUT

Outcome Measures

Primary Outcomes (1)

• The accuracy of combined diagnosis in evaluating renal parenchymal damage of CAKUT patients

  The accuracy of combined diagnosis includes sensitivity and specificity. The reference standard test (DMSA scan) and combined diagnosis are conducted in the cohort of pediatric children diagnosed of CAKUT. Sensitivity is defined as: The proportion of renal parenchymal damage is successfully screened out by combined diagnosis. Specificity is defined as: The proportion of children without renal parenchymal damage who are not recognized as impairment by combined diagnosis.

  Within 3 months since diagnosis of CAKUT.

Study Arms (1)

pediatric patients with CAKUT

This cohort is composed of pediatric children diagnosed of CAKUT from Shanghai peri-conceptional parent-offspring cohort (SPCC) clinic research related outpatient and high-risk newborns referral outpatient, and those who are enrolled in nephrology department and urinary surgery department with CAKUT diagnosis. By diagnostic tests for predicting renal parenchymal damage in this cohort, data of kidney images, urinary biomarkers and disease genes can be collected.

Diagnostic Test: combined diagnosis of renal parenchymal damage

Interventions

combined diagnosis of renal parenchymal damage DIAGNOSTIC_TEST

This study is an observational study to evaluate the accuracy of renal parenchymal damage combined diagnosis with no intervention. All patients from the cohort accept MRI-DWI scan，the urinary biomarkers detection, disease gene detection and DMSA scan. 1. This combined diagnosis includes MRI-DWI scan and the urinary biomarkers detection. MRI-DWI： All the scans are performed using the MagnetomVerio 3.0T magnetic resonance imaging system from Siemens. Urinary polypeptide collection: Urine samples requirements: volume between 50-100ml, specific gravity \>1.010. Immunomagnetic beads isolation technique is used to collect polypeptide. 2. The reference standard is DMSA scan: Intravenous injection of 99mTC-DMSA5mCi is followed by anterior and posterior planar imaging of the renal area 1 hour later. The DMSA scan images are read by 2 trained radiologists and confirmed by the special doctor of the center for diagnosis and treatment of renal and urinary diseases at the same time.

pediatric patients with CAKUT

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric children diagnosed of CAKUT from Shanghai peri-conceptional parent-offspring cohort (SPCC) clinic research related outpatient and high-risk newborns referral outpatient, and those who are enrolled in nephrology department and urinary surgery department with CAKUT diagnosis.

You may qualify if:

• Patient that was diagnosed clinically and genetically as:
• Renal parenchymal aplasia or ectopia, including simple renal aplasia,Multicystic Dysplastic Kidney, kidney tubules dysplasia, and hereditary cystic kidney. ①disease renal agenesis (RA): With ultrasound diagnosis of unilateral renal absence.②Renal hypoplasia (RH)/renal dysplasia (RD) is usually defined as renal volume less than two standard deviations of the average of the same age, or renal total volume less than 50% of the normal value of the same age. RD refers to the presence of undifferentiated or not metaplastic tissue in the kidney, with or without renal volume reduction. Diagnosis is based on the ultrasonic findings of multicystic dysplastic kidney (MCDK) and the diagnosis of unilateral or bilateral renal functional defects by means of isotopic renal functional imaging (DMSA or DTPA);
• Kidney tubular dysplasia: ①the diagnosis of polycystic kidney disease(ADPKD/ARPKD) is mainly dependent on imaging; Patients with a family history of ADPKD can be diagnosed with more than 3 renal cysts on either side. those who with bilateral renal diffuse enlargement with multiple cysts should be clinically considered with PKD even without family history of ADPKD, and relevant gene screening is recommended.②Simple renal cyst: single renal cyst was found by ultrasound or other imaging examination;③Nephronophthisis, NPHP: ultrasonography showed enhanced renal echo or unclear boundary between cortex and medulla, with or without genetic diagnosis or involvement of other system, gene sequence should be considered. Genetic molecular diagnosis is the main diagnostic basis of NPHP diagnosis.④nephrocalcinosis and urinary calculi: the diagnosis depends on the ultrasound diagnosis and the examinations of serum and urine electrolyte and metabolite should be performed to further diagnose the primary disease.
• Abnormalities of Ureter， renal pelvis and/or bladder: ① Dual collection system: Reduplication of kidney or renal pelvis/ureter depends on ultrasound, magnetic resonance imaging (MRI) diagnosis. ② Urinary obstruction: Including ureteropelvic junction obstruction, ureterovesical junction obstruction or insufficiency. The diagnosis of obstruction depends on magnetic resonance urography (MRU) and isotopic dynamic renal imaging(DTPA) ③ vesicoureteral reflux: The diagnosis depends on voiding cysternography (VCUG).
• Urinary tract anomalies: ① Urethral absence/urethra atresia/ectopic orifice: Diagnosis depends on physical examination and VCUG examination. ② Posterior urethral valve: Severe hydronephrosis can be found by ultrasound, and the diagnosis depends on VCUG examination.

You may not qualify if:

• Patient with renal failure due to different causes but without urine specimen;

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Cakut

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 3, 2020
• Study Start: January 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

CN (1)