Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04537364
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2020-08-28
Brief Title:
Prediction of Renal Parenchymal Damage of CAKUT
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
Official Title:
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
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 MRIDWI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None