Prediction of Renal Parenchymal Damage of CAKUT
Condition: CAKUT
Study type: Observational

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.
    

Intervention name(s): combined diagnosis of renal parenchymal damage
Intervention type(s): Diagnostic Test
Intervention description(s): 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.
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.
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.
Observational model: Cohort
Time perspective: Prospective
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.