Biomarkers and Inflammation in Solid Organ Transplantation: Relationship With Short- and Long-Term Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Solid Organ Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a prospective, tissue-based, low-risk, non-pharmacological study that will include adult patients undergoing solid organ transplantation (heart, liver, lung, kidney) followed at the following Units of the IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO): * Heart Failure and Transplants (heart-lung) * Internal Medicine for the Treatment of Severe Organ Failures (liver) * Nephrology, Dialysis, and Transplantation (kidney).
Detailed description
The aim of this study is to perform objective biological measurements of inflammation and cellular senescence (i.e., plasma profiles of cytokines, inflammatory miRNAs, circulating free DNA, extracellular vesicles), immunosenescence (i.e., circulating and tissue-based leukocyte profiles of aging), and systemic and tissue aging (i.e., epigenetic clocks) in the collected cohort. These measures may help to stratify patients at higher risk of transplant failure (graft damage) or those at higher risk of cardiovascular, renal, metabolic, neoplastic complications, or increased mortality. Additionally, the study aims to implement therapeutic or prophylactic measures based on biological stratification to prevent the progression of biological damage.
It is also important to highlight that the identification of markers of cellular senescence, immunosenescence, and epigenetic aging in the recipient could define patterns that guide more appropriate and personalized immunosuppressive treatments.
Primary outcome measures
- Adverse Events in Heart Transplantation [Time frame: 7 years]
- Adverse Events in Liver Transplantation [Time frame: 7 years]
- Adverse Events in Lung Transplantation [Time frame: 7 years]
- Adverse Events in Kidney Transplantation [Time frame: 7 years]
Eligibility criteria
Inclusion criteria
- Adult patients (≥ 18 years old at the time of enrollment) who have undergone at least one of the following: Liver transplant, Kidney transplant, Heart transplant, Lung transplant during the study period.
- Informed consent acquisition.
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 3 centers
- IRCCS - Azienda ospedaliero-universitaria di Bologna — Bologna
- IRCCS - Azienda ospedaliero-universitaria di Bologna — Bologna
- IRCCS - Azienda ospedaliero-universitaria di Bologna — Bologna
Identifiers
NCT: NCT06774339 · Bio-Trap · RC-2024-2790630