Solid Organ TransplantationBio-TrapNCT06774339
Biomarkers and Inflammation in Solid Organ Transplantation: Relationship With Short- and Long-Term Outcomes
An observational study of Solid Organ Transplantation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Organ Transplantation
- How many people
- 250 participants
- Where
- 3 sitesItaly
- Study dates
- 10 Oct 2024to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS - Azienda ospedaliero-universitaria di Bologna
Bologna, 40138
Marco Masetti, MD, 0512143725, scompenso.trapiantocuore@aosp.bo.it
- Recruiting
IRCCS - Azienda ospedaliero-universitaria di Bologna
Bologna, 40138
Maria Cristina Morelli, MD, 0512144248, mariacristina.morelli@aosp.bo.it
Maria Cristina Morelli, MD
- Recruiting
IRCCS - Azienda ospedaliero-universitaria di Bologna
Bologna, 40138
Gaetano La Manna, MD, 0512144577, gaetano.lamanna@unibo.it
About this study
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).
Read the 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.
- Conditions
- Solid Organ Transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start10 Oct 2024
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ TransplantationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco G Masetti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774339
- Sponsor's protocol ID
- Bio-Trap
- Other IDs
- RC-2024-2790630
- Acronym
- Bio-Trap
- Status last verified
- Dec 2024
- First submitted
- 9 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Inflammation in Solid Organ Transplantation: Relationship With Short- and Long-Term Outcomes
- ClinicalTrials.gov ID
- NCT06774339
- Acronym / sponsor ID
- Bio-Trap / Bio-Trap
- Conditions
- Solid Organ Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse Events in Heart Transplantation
Time frame: 7 years
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.
Adverse Events in Liver Transplantation
Time frame: 7 years
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)
Adverse Events in Lung Transplantation
Time frame: 7 years
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.
Adverse Events in Kidney Transplantation
Time frame: 7 years
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
Related trials for Solid Organ Transplantation
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingPhase 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection, Transplantation Infection
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Active, not recruitingPhase 2
Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant
Solid Organ Transplant, Viral Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco G Masetti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Organ Transplantation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Masetti, MD (0512143725, scompenso.trapiantocuore@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events in Heart Transplantation (time frame: 7 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.