CAKUTNCT04537364
Prediction of Renal Parenchymal Damage of CAKUT
An observational study of CAKUT, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- CAKUT
- What is being tested?
- combined diagnosis of renal parenchymal damage
- Type of treatment
- Injection or infusion
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient with renal failure due to different causes but without urine specimen;
- Other conditions that the researcher considers not suitable for inclusion
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Being tested
- combined diagnosis of renal parenchymal damage
- Medical subject headings
- Cakut
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined diagnosis of renal parenchymal damageDiagnostic 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: combined diagnosis of renal parenchymal damage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months since diagnosis of CAKUT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Jan 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAKUTStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537364
- Sponsor's protocol ID
- RPD-CAKUT1
- Status last verified
- Nov 2023
- First submitted
- 28 Aug 2020
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04537364
- Acronym / sponsor ID
- RPD-CAKUT1
- Conditions
- CAKUT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patients with CAKUT | – | Diagnostic Test: combined diagnosis of renal parenchymal damageThis 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. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient with renal failure due to different causes but without urine specimen;
- Other conditions that the researcher considers not suitable for inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined diagnosis of renal parenchymal damageThis 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. | Diagnostic test | pediatric patients with CAKUT |
Primary outcome
The accuracy of combined diagnosis in evaluating renal parenchymal damage of CAKUT patients
Time frame: Within 3 months since diagnosis of CAKUT.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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Ultrasound Localization Microscopy in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CAKUT, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of combined diagnosis in evaluating renal parenchymal damage of CAKUT patients (time frame: Within 3 months since diagnosis of CAKUT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.