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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
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease
Posterior Urethral Valves

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Renal/patient survival at 2 years post-natally. [ Time Frame: Year 2 ]
    Defined by the need for dialysis or death.


Secondary Outcome Measures :
  1. 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
serum urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mothers (18 years old and more) carrying male fetuses with suspected PUV
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Stéphane DECRAMER, Pr 5 34 55 84 58 ext 33 decramer.s@chu-toulouse.fr
Contact: Françoise CONTE-AURIOL auriol.f@chu-toulouse.fr

Locations
Show Show 29 study locations
Sponsors and Collaborators
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Stéphane DECRAMER, Pr CHU Toulouse
Publications:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03116217    
Other Study ID Numbers: 16/8805
2016-A01914-47 ( Other Identifier: ID-RCB )
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
renal function
post natal
peptidome