Status:
NOT_YET_RECRUITING
"A Privacy-protecting Environment for Child Transplants Health Related and Genomic Data Integration in the European Reference Network"
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Conditions:
Transplant Complication
Kidney Transplant
Eligibility:
All Genders
6-18 years
Brief Summary
Protect\_Child\_101 is an observational study to be performed in children that have undergone a liver or renal transplant. The aim of this study is to analyse small variations in the genetic material...
Eligibility Criteria
Inclusion
- ● Paediatric patients (6 months to 18 years old) with liver or kidney transplant.
- Both patients with de novo transplantation or in follow-up can be included in the study.
- For the retrospective cohort, only patients within the first 5 years after transplantation will be included.
- Patients and/or parents agreeing to participate in the study and provide consent for the obtention of clinical data and samples for genomic and methylomic analysis and the use of the information according to the protocol.
Exclusion
- Patients that are not being followed up in the clinical site.
- Subjects alternating between different clinical sites. Subjects/Tutors that don't understand the informed consent form.
- Subject or their legally authorized representative does not sign the informed consent document.
- Re-transplantation or AB0-incompatible transplantation.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07194057
Start Date
September 30 2025
End Date
January 1 2028
Last Update
September 26 2025
Active Locations (4)
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1
University Medical Center Hamburg-Eppendorf (UKE),
Hamburg, Germany, 20251
2
Mediterranean Institute for Transplantation (ISMETT)
Palermo, Sicily, Italy, 90127
3
University Hospital Padova
Padua, Italy, 35128
4
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046