Actively Recruiting

Age: 18Years +
All Genders
ID06774339

Biomarkers and Inflammation in Solid Organ Transplantation: Relationship With Short- and Long-Term Outcomes

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-14

250

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying adult patients who have received solid organ transplants, including heart, liver, lung, or kidney transplants. This observational study aims to measure biological markers related to inflammation, cellular aging, and immune system aging in these patients. The goal is to better understand risks for transplant failure and complications and to guide personalized treatments to improve long-term outcomes. The study involves collecting tissue and blood samples to analyze plasma profiles of cytokines, inflammatory microRNAs, circulating free DNA, extracellular vesicles, and leukocyte profiles. Researchers will also assess systemic and tissue aging through epigenetic clocks. These measurements may help identify patients at higher risk for transplant damage, cardiovascular, kidney, metabolic, or cancer complications, and increased mortality. Participants will be followed for up to seven years to monitor adverse events related to their organ transplant. Biological samples and data will be collected and analyzed to track inflammation and aging markers. This will help researchers evaluate the relationship between these markers and transplant outcomes. The study will monitor safety and effectiveness of any therapeutic or preventive measures based on this biological stratification.

CONDITIONS

Brief Title

Biomarkers and Inflammation in Solid Organ Transplantation: Relationship With Short- and Long-Term Outcomes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (18 years or older at 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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 7 years

Participants who have undergone solid organ transplantation are observed to measure biological markers related to inflammation, cellular senescence, immunosenescence, and aging. These measurements help assess risk for transplant failure and other complications over time.

Periodic visits depending on transplant type and participant status

Trial Site Locations

Total: 3 locations

1

IRCCS - Azienda ospedaliero-universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

2

IRCCS - Azienda ospedaliero-universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

3

IRCCS - Azienda ospedaliero-universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

M

Marco Masetti, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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