Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03116217

Acronym

Antenatal

Enrollment

400

Registered

2017-04-17

Start date

2017-06-26

Completion date

2023-12-26

Last updated

2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Urethral Valves

Keywords

renal function, post natal, peptidome

Brief summary

Validate the use of fetal urine peptidome-analysis and explore amniotic fluid markers for the stratification of fetuses with Posterior Urethral Valve for post-natal renal function.

Detailed description

The ANTENATAL project requires the use of fetal urine as well as post-natal urine, post-natal serum and, possibly, amniotic liquid. We will take an additional tube during the takings collected for routine management of the disease. The analysis of samples will be carried out in Toulouse at the Institute of Metabolic and Cardiovascular Diseases or with fee-for-service suppliers.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* male singleton fetus with megabladder associated with urinary tract anomalies with or without dysplastic or hyperechogenic parenchyma detected in a first ultrasound; * megabladder confirmed in a second ultrasound; * collection of fetal urine taken during the routine management of the disease for the dosage of ß2-microglobulin; * written informed consent.

Exclusion criteria

* refusal to participate in the study; * person protected by law.

Design outcomes

Primary

Measure	Time frame	Description
Renal/patient survival at 2 years post-natally.	Year 2	Defined by the need for dialysis or death.

Secondary

Measure	Time frame	Description
Renal function of the survivors at day 4 and 6 and 12 month post-natally.	Year 1	This post-natal renal function, estimated via serum cystatin C concentrations, will be analysed centrally in Toulouse to homogenise the analysis.

Countries

Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom

Contacts

Primary ContactStéphane DECRAMER, Pr

decramer.s@chu-toulouse.fr5 34 55 84 58

Backup ContactFrançoise CONTE-AURIOL

auriol.f@chu-toulouse.fr

Outcome results