Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves (Antenatal)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03116217|
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : September 13, 2018
|Condition or disease|
|Posterior Urethral Valves|
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.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves|
|Actual Study Start Date :||June 26, 2017|
|Estimated Primary Completion Date :||December 26, 2023|
|Estimated Study Completion Date :||December 26, 2023|
- Renal/patient survival at 2 years post-natally. [ Time Frame: Year 2 ]Defined by the need for dialysis or death.
- Renal function of the survivors at day 4 and 6 and 12 month post-natally. [ Time Frame: Year 1 ]This post-natal renal function, estimated via serum cystatin C concentrations, will be analysed centrally in Toulouse to homogenise the analysis.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116217
|Contact: Stéphane DECRAMER, Pr||5 34 55 84 58 ext email@example.com|
|Contact: Françoise CONTE-AURIOLfirstname.lastname@example.org|
|Principal Investigator:||Stéphane DECRAMER, Pr||CHU Toulouse|