"A Privacy-protecting Environment for Child Transplants Health Related and Genomic Data Integration in the European Reference Network" (Protect_Child)

Instituto de Investigación Hospital Universitario La Paz

Status: Not yet enrolling

Conditions: Kidney Transplant; Transplant Complication; Liver Transplant

Treatments: Genetic: Polygenic Risk Score Calculation; Diagnostic Test: Methylome and episignatures; Genetic: Whole genome sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT07194057

PI-6796

Details and patient eligibility

About

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 (DNA) of transplanted children. The investigators will also study a type of chemical 'marks' called methylations, which do not change the DNA itself, but can affect how it functions. These marks can influence how certain diseases develop or how the body responds to transplantation.

Specifically, investigators seek to discover:

• Whether there are genetic or epigenetic (methylation) alterations that may explain why some children develop serious diseases that require transplantation.
• If these alterations can help us predict possible complications after transplantation, such as organ rejection, infections, organ failure, cancer development.

Within this study, data from the child's medical history will be collected. The data to be collected are demographic data (gender, age, ethnicity), clinical data, personal and family history possibly related to his/her disease, course and evolution of the disease, and complementary and laboratory examinations collected from his/her clinical history.

The only non-routine tests to be performed will be the genomic and methylomic tests. Nevertheless, these determinations will be performed on samples obtained during the child's routine care. No extra intervention is planned as part of this study.

Samples and clinical data will be collected at different time points after transplantation. Schematically, collection is planned for months 0, 1, 3, 6, 12 and 24 post-transplant. In addition to these pre-established points, comprehensive data collection will be attempted when the child suffers a relevant clinical event, e.g. infection, treatment toxicity, organ rejection (post-transplant complication).

Enrollment: 200 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ● 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 criteria

• 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.

Trial design

200 participants in 2 patient groups

Paediatric kidney and liver transplant that suffered a clinical event of interest after transplant

Description:

This cohort is made up of paediatric kidney and liver patients that had a clinical event after transplantation. The main clinical events of interest of this study are: viral infections, bacterial infections, drug-related toxicity and rejection. All patients will undergo genomic and methylomic tests to diagnose biological risk factors that could help determine the risk of developing the clinical event of interest.

Treatment:

Genetic: Whole genome sequencing

Diagnostic Test: Methylome and episignatures

Genetic: Polygenic Risk Score Calculation

Paediatric kidney and liver transplant patients with no events after transplant

Description:

This cohort is made up of paediatric kidney and liver patients that did not develop a clinical event after transplantation. All patients will undergo genomic and methylomic tests. The genetic and methylomic results will be compared to those of the patients that developed a clinical event. The objetive is to identify biological risk factors that could help determine the risk of developing the clinical event of interest.

Treatment:

Genetic: Whole genome sequencing

Diagnostic Test: Methylome and episignatures

Genetic: Polygenic Risk Score Calculation