Congenital Urine Flow ImpairmentACEUNCT02792348
Change of Urinary Metabolic Profile Secondary to a Congenital Urine Flow Impairment (UFI) by Nuclear Magnetic Resonance (NMR) and Metabolomics Analysis
An observational study of Congenital Urine Flow Impairment, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
For the new-born, diagnosis and prognosis of congenital urine flow impairment (UFI) are difficult to confirm only with morphological examination (ultrasonography, intravenous pyelography) and functional examination (dynamic renal scan MAG3). Read more about this study
- Who is it for?
- Ages 1 month to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Congenital Urine Flow Impairment
- What is being tested?
- Laboratory biomarker analysis on urine sample
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Dec 2016
- 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 month to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: All patients (newborns or infants between 1 and 3 months of age) will be enrolled outpatient uro-visceral service of HFME hospital.
Who may be able to join
- Newborns or infants between 1 and 3 months of age,
- who present an upper urinary tract dilatation detected on prenatal ultrasound scanning, and confirmed with a postnatal sonographic investigation between D4 and D10 of life showing a renal pelvis with an anteroposterior diameter > 10 mm and/or an ureters > 6 mm,
- Written, informed consent obtained from the 2 parents
- Newborns or infants between 1 and 3 months of age,
- Written, informed consent obtained from the 2 parents
- Non-inclusion Criteria - UFI group:
Show all 12Show fewer
- urological associated anomaly: bladder dysfunction, solitary kidney, bilateral pathology,
- Absence of parents consent
- Non-inclusion Criteria - control group:
- Nephrologic or urological anomaly
- Previous medical conditions or prior surgery; except minor surgery (inguinal hernia, umbilical hernia, hypertrophic pyloric stenosis…..)
- Absence of parents consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
For the new-born, diagnosis and prognosis of congenital urine flow impairment (UFI) are difficult to confirm only with morphological examination (ultrasonography, intravenous pyelography) and functional examination (dynamic renal scan MAG3). Only the test of time allows the post confirmation of a significant UFI requiring a surgery. This meant that the actual therapeutic indications are imperfect by the absence of an "absolute" endpoint for UFI.
The objective of the study is to characterize the urinary metabolomics profile of new born with renal pelvis and/or ureters tract dilatation (suspicion of pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux), detected by prenatal ultrasonography, by Nuclear Magnetic Resonance (NMR) and metabolomics analysis. This characterization will allow the identification of statistically significant metabolomics markers for the diagnosis and prognosis of a favourable evolution of the anomaly. The evolution with time of these metabolomics profiles will also considered.
- Conditions
- Congenital Urine Flow Impairment
- Being tested
- Laboratory biomarker analysis on urine sample
- Keywords
- congenital urine flow impairment, urinary metabolomics profile, Nuclear Magnetic Resonance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory biomarker analysis on urine sampleOther
Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance
| Study group | Role | What they receive |
|---|---|---|
| children with congenital urine flow impairment | this group contain children with an unilateral urinary tract dilatation diagnosed by prenatal ultrasonography Receives: Other: Laboratory biomarker analysis on urine sample | |
| control group | this group contains children, between 1 and 3 months of age, without nephrological or urological anomaly Receives: Other: Laboratory biomarker analysis on urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
NMR identification of urinary metabolomics markers for diagnosis and prognosis of UFI (suspicion of pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux) detected in prenatal ultrasonography.
Urine will be stored at _80 _C before acquisition of the NMR data. Urine samples will be thawed at room temperature before use. 400µL of supernatant will be diluted with 200 µL of a buffer solution Na2HPO4/NaH2PO4 (pH = 7.4; 20% D2O/H2O v.v, internal reference: 3-(trimethylsilyl)propionic,2-2-3-3-d4 acid) in Eppendorf tubes. Each sample will be centrifuged for 5 min at 4°C at 12,000 g. Finally, 550 µL will be transferred into 5 mm NMR tubes for analysis. Standard 1H 1D NMR pulse sequences, NOESY and CPMG with water presaturation, will be applied on each sample to obtain corresponding metabolic profiles. In addition, 2D NMR experiments (1H-1H TOCSY or 1H-13C HSQC, and 1H J-Resolved) will be recorded to achieve structural assignment of the metabolic signals.
Measured: Urine samples of patients will be collected at recruitment time (Day 0).
Secondary outcomes (1)
change of the urinary metabolomics profile change of UFI (pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux) during the follow-up.
Urine will be stored at _80 _C before acquisition of the NMR data. Urine samples will be thawed at room temperature before use. 400µL of supernatant will be diluted with 200 µL of a buffer solution Na2HPO4/NaH2PO4 (pH = 7.4; 20% D2O/H2O v.v, internal reference: 3-(trimethylsilyl)propionic,2-2-3-3-d4 acid) in Eppendorf tubes. Each sample will be centrifuged for 5 min at 4°C at 12,000 g. Finally, 550 µL will be transferred into 5 mm NMR tubes for analysis. Standard 1H 1D NMR pulse sequences, NOESY and CPMG with water presaturation, will be applied on each sample to obtain corresponding metabolic profiles. In addition, 2D NMR experiments (1H-1H TOCSY or 1H-13C HSQC, and 1H J-Resolved) will be recorded to achieve structural assignment of the metabolic signals.
Measured: Urine samples of patients will be collected at the follow-up visits between 9 and 12 months of age (M9-M12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startFeb 2011
- Primary completionJan 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Urine Flow ImpairmentStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792348
- Sponsor's protocol ID
- D50720
- Acronym
- ACEU
- Status last verified
- Jun 2016
- First submitted
- 2 Jun 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Urinary Metabolic Profile Secondary to a Congenital Urine Flow Impairment (UFI) by Nuclear Magnetic Resonance (NMR) and Metabolomics Analysis
- ClinicalTrials.gov ID
- NCT02792348
- Acronym / sponsor ID
- ACEU / D50720
- Conditions
- Congenital Urine Flow Impairment
- Keywords
- congenital urine flow impairment, urinary metabolomics profile, Nuclear Magnetic Resonance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Jun 2016 (estimated)
- 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.
For the new-born, diagnosis and prognosis of congenital urine flow impairment (UFI) are difficult to confirm only with morphological examination (ultrasonography, intravenous pyelography) and functional examination (dynamic renal scan MAG3). Only the test of time allows the post confirmation of a significant UFI requiring a surgery. This meant that the actual therapeutic indications are imperfect by the absence of an "absolute" endpoint for UFI.
The objective of the study is to characterize the urinary metabolomics profile of new born with renal pelvis and/or ureters tract dilatation (suspicion of pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux), detected by prenatal ultrasonography, by Nuclear Magnetic Resonance (NMR) and metabolomics analysis. This characterization will allow the identification of statistically significant metabolomics markers for the diagnosis and prognosis of a favourable evolution of the anomaly. The evolution with time of these metabolomics profiles will also considered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with congenital urine flow impairment | – | Other: Laboratory biomarker analysis on urine samplethis group contain children with an unilateral urinary tract dilatation diagnosed by prenatal ultrasonography |
| control group | – | Other: Laboratory biomarker analysis on urine samplethis group contains children, between 1 and 3 months of age, without nephrological or urological anomaly |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All patients (newborns or infants between 1 and 3 months of age) will be enrolled outpatient uro-visceral service of HFME hospital.
Key inclusion criteria (12 listed)
- Non-inclusion Criteria - UFI group:
- Non-inclusion Criteria - control group:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Laboratory biomarker analysis on urine sampleArchived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance | Other | children with congenital urine flow impairment, control group |
Primary outcome
NMR identification of urinary metabolomics markers for diagnosis and prognosis of UFI (suspicion of pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux) detected in prenatal ultrasonography.
Time frame: Urine samples of patients will be collected at recruitment time (Day 0).
Urine will be stored at _80 _C before acquisition of the NMR data. Urine samples will be thawed at room temperature before use. 400µL of supernatant will be diluted with 200 µL of a buffer solution Na2HPO4/NaH2PO4 (pH = 7.4; 20% D2O/H2O v.v, internal reference: 3-(trimethylsilyl)propionic,2-2-3-3-d4 acid) in Eppendorf tubes. Each sample will be centrifuged for 5 min at 4°C at 12,000 g. Finally, 550 µL will be transferred into 5 mm NMR tubes for analysis. Standard 1H 1D NMR pulse sequences, NOESY and CPMG with water presaturation, will be applied on each sample to obtain corresponding metabolic profiles. In addition, 2D NMR experiments (1H-1H TOCSY or 1H-13C HSQC, and 1H J-Resolved) will be recorded to achieve structural assignment of the metabolic signals.
1 secondary outcome
change of the urinary metabolomics profile change of UFI (pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux) during the follow-up.
Time frame: Urine samples of patients will be collected at the follow-up visits between 9 and 12 months of age (M9-M12).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
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 Congenital Urine Flow Impairment, run by Hospices Civils de Lyon at 1 site in France.
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 12 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 7 Jun 2016. 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 France. 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?
Results are not available in the source record.
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?
NMR identification of urinary metabolomics markers for diagnosis and prognosis of UFI (suspicion of pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux) detected in prenatal ultrasonography. (time frame: Urine samples of patients will be collected at recruitment time (Day 0).). 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 7 Jun 2016.