Biomarkers and Inflammation in Solid Organ Transplantation: Relationship With Short- and Long-Term Outcomes (Bio-Trap)

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).

Study Overview

• Status: Recruiting
• Conditions: Solid Organ Transplantation

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Marco Masetti, MD; Phone Number: 0512143725; Email: scompenso.trapiantocuore@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS - Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Gaetano La Manna, MD; Phone Number: 0512144577; Email: gaetano.lamanna@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events in Heart Transplantation	We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Primary Graft Dysfunction (PGD), Acute Rejection, Death from any cause, Chronic Rejection, and Major Infectious Complications.	7 years
Adverse Events in Liver Transplantation	We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Primary Graft Dysfunction (PGD), Acute Rejection, Death from any cause, Chronic Rejection, Major Infectious Complications and Major Cardiovascular Complications (MACE)	7 years
Adverse Events in Lung Transplantation	We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Acute Rejection, Death from any cause, Chronic Rejection, Major Infectious Complications and Endoscopic Complications.	7 years
Adverse Events in Kidney Transplantation	We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Delayed Graft Function (DGF), Acute Rejection, Graft Loss, Death from any cause, Chronic Rejection, and Major Cardiovascular Complications (MACE).	7 years

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Marco G Masetti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: Bio-Trap; RC-2024-2790630 (Other Grant/Funding Number: Ricerca corrente 2024-2026 - Ministero della Salute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No