NCT04537364

Prediction of Renal Parenchymal Damage of CAKUT

Protocol for a Cohort Diagnostic Accuracy Study to Develop Prediction of Renal Parenchymal Damage and to Evaluate Accuracy of Renal Function in Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 234 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Congenital anomalies of kidney and urinary tract (CAKUT) is one of the common birth defects, with a morbidity of 6‰. The delayed diagnosis, due to its demanding diagnostic technique, may leads to long-term severe renal damage. This project is a prospective, continuous double-blind designed diagnostic accuracy study. The clinical diagnosis of CAKUT relies on a panel of radiological examinations most of which are invasive and risk of radiation harm for children. To establish the non-invasive and safe diagnosis detections of renal damage of CAKUT in children, a combination of MRI/DWI with urinary detection through Immunomagnetic beads isolation technique is to carried out to evaluate the renal deficiency in CAKUT comparing the dimercaptosuccinic acid (DMSA) scan as the golden standard of renal parenchymal damage. Analysis of sensitivity and specificity is to evaluate the accuracy of the combined diagnostic protocol. Furthermore the clinical information of pregnancy and phenotypes of the patients with CAKUT is to be collected with all the genetic information constructing the full phenotype- genotype spectrum for big data analysis and predictive model for early detection of renal damage in CAKUT.

Conditions

• CAKUT

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	combined diagnosis of renal parenchymal damage	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2020-09-03
• Last updated: 2023-11-09

Locations

1 site across 1 country: China