Clinical trial NCT06774339: Biomarkers and Inflammation in Solid Organ Transplantation: Relationship With Short- and Long-Term Outcomes
Official title: Biomarkers and Inflammation in Solid Organ Transplantation: Relationship With Short- and Long-Term Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Organ Transplantation
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients listed for solid organ transplantation (liver, kidney, heart, lung) at the IRCCS Azienda Ospedaliero-Universitaria di Bologna will be enrolled during the study period.

Brief summary: 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.

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

Primary outcomes:
measure: Adverse Events in Heart Transplantation
timeFrame: 7 years
measure: Adverse Events in Liver Transplantation
timeFrame: 7 years
measure: Adverse Events in Lung Transplantation
timeFrame: 7 years
measure: Adverse Events in Kidney Transplantation
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS - Azienda ospedaliero-universitaria di Bologna
city: Bologna
country: Italy
facility: IRCCS - Azienda ospedaliero-universitaria di Bologna
city: Bologna
country: Italy
facility: IRCCS - Azienda ospedaliero-universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Marco G Masetti, MD
role: PRINCIPAL_INVESTIGATOR
References: