Using gene analysis to improve diagnosis of liver transplant rejection
Transcriptomics as an Aid in the Histological Diagnosis of Acute Rejection After Liver Transplantation
This study is testing whether analyzing specific genes in liver transplant patients can help doctors diagnose rejection faster and more accurately.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06734013 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients under 18 years old will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.