Using gene analysis to improve diagnosis of liver transplant rejection
Official title: Transcriptomics as an Aid in the Histological Diagnosis of Acute Rejection After Liver Transplantation
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06734013 · Data updated 2026-11-12
This study is testing whether analyzing specific genes in liver transplant patients can help doctors diagnose rejection faster and more accurately.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | October 17, 2024 |
| Main results expected | May 2, 2025 |
| Study ends | June 2025 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT06734013 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have been diagnosed with post-liver transplant rejection and have available tissue for analysis.
✕Probably not a fit
Patients under 18 years old will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This exploratory study aims to identify specific genes associated with acute rejection in liver transplant patients by analyzing biopsy samples. A panel of indicator genes related to both humoral and cell-mediated rejection will be selected from existing literature and applied to these samples. The study seeks to enhance molecular diagnostics to support traditional histological methods, potentially allowing for quicker and more accurate diagnosis of rejection. By identifying early cellular signals related to rejection, the study hopes to improve patient stratification and treatment decisions.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses of acute rejection in liver transplant patients, improving patient outcomes.
How similar studies have gone: While the approach of using molecular diagnostics in this context is recommended by recent guidelines, it remains largely untested in clinical practice, making this study a novel exploration.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a diagnosis of post-OLT rejection prior to the visit at which they will be enrolled, with tissue available for RT-PCR investigations * Age ≥ 18 years * Informed consent Exclusion Criteria: * Age \<18 years
Where it's running
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy Recruiting
Study contacts
- Principal investigator: Deborah Malvi, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Deborah Malvi, MD
- Email: deborah.malvi@aosp.bo.it
- Phone: 0512143761
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Analyzing liver grafts to predict transplant outcomes
This study is testing if certain markers in liver grafts can help predict how well the transplant will work for patients receiving the liver.
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This trial will test whether lower doses of steroids work as well as higher doses to treat acute T cell–mediated rejection in people who have had a kidney or simultaneous kidney–pancreas transplant.
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Investigating white blood cells to develop new therapies for autoimmune diseases
This study is trying to learn more about white blood cells from volunteers to help create new treatments for autoimmune diseases.
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Immune biomarkers to predict complications after liver transplantation
This study tests immune biomarkers in adults after liver transplant to see if changes in markers relate to infections, rejection, or viral reactivation within the first year.
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Non-invasive test to predict early heart rejection in pediatric transplant patients
This study tests non-invasive heart tests like cardiac MRI and blood markers to see if they can detect rejection in kids after heart transplant, potentially reducing the need for invasive biopsies.
-
Multimodal prospective approach to understand acute and chronic lung transplant rejection
This project will see if blood tests, airway sampling, imaging, and genetic analyses can identify which adults who have had or are being evaluated for a lung transplant will develop antibody‑mediated rejection and later chronic graft dysfunction.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.