Rejection; Transplant, LiverNCT06734013
Transcriptomics as an Aid in the Histological Diagnosis of Acute Rejection After Liver Transplantation
A study testing Molecular diagnostic in people with Rejection; Transplant, Liver, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The primary objective of this exploratory study is to identify genes associated with acute rejection in liver transplant patients. To this end, a panel of acute rejection indicator genes (both humoral and cell-mediated) will be selected from results published in the literature and applied to biological material… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rejection; Transplant, Liver
- What is being tested?
- Molecular diagnostic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 17 Oct 2024to Jun 2025
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Deborah Malvi, MD, 0512143761, deborah.malvi@aosp.bo.it
Deborah Malvi, MD
About this study
The primary objective of this exploratory study is to identify genes associated with acute rejection in liver transplant patients. To this end, a panel of acute rejection indicator genes (both humoral and cell-mediated) will be selected from results published in the literature and applied to biological material derived from biopsies. The secodnary objective is to identify genes associated with the diagnosis of humoral acute rejection and those associated with the diagnosis of cell-mediated acute rejection.
Read the detailed description
The possibility of introducing molecular diagnostics in support of histological and clinical diagnostics (still not routinely applied today but recommended by the most recent guidelines) will result in faster and more precise diagnostics, capable of highlighting early activation of cellular signals related to rejection in the absence yet of a frank clinical and histological picture. This will lead to a better diagnostic stratification of these patients, with the possibility of rationalising the choice of therapy.
AIMS: The primary objective of this exploratory study is to identify genes associated with acute rejection in liver transplant patients. To this end, a panel of acute rejection indicator genes (both humoral and cell-mediated) will be selected from published results in the literature and applied to biological material derived from biopsies. The secodnary objective is to identify genes associated with the diagnosis of humoral acute rejection and those associated with the diagnosis of cell-mediated acute rejection.
ENDPOINT/S: diagnostic (No of cases) of acute rejection; possible specific diagnosis of acute cell-mediated and humoral rejection.
STUDY DESIGN: The study is single-centre, observational, tissue-based, cross-sectional, exploratory, retrospective and prospective. Approximately 40 patients are expected to be enrolled, 20 retrospective and 20 prospective. All patients will be treated according to clinical practice: clinical and histological data will be collected in pseudonymous form. Routine histological and immunohistochemical investigations as well as RT-PCR analysis will be performed on the biopsy tissue (FFPE material). To assess the diagnostic sensitivity with regard to rejection status, and for panel development, a retrospective cohort of consecutive cases with acute rejection will be enrolled; for the prospective cohort, consecutive patients requiring liver biopsy for diagnostic indications will be enrolled.
STUDY POPULATION: The study will enrol patients undergoing OLT who require a liver biopsy for diagnostic indications. There is no restriction of sex or underlying pathology. Retrospective case enrolment is planned within the first 6 months of 2024. Prospective case enrolment will take place during 2024. Patients will be enrolled at the U.O. of Internal Medicine for the Treatment of Severe Organ Failures, IRCCS - Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola, where the biopsy will be performed as standard of care.
- Conditions
- Rejection; Transplant, Liver
- Being tested
- Molecular diagnostic
- Keywords
- Liver transplant
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular diagnosticDiagnostic test
RNA will be analysed using a Real-Time PCR expression card (TaqMan Real-Time PCR assay technology - Thermo Fisher Scientific). The analysis will be performed using a Real-Time Light Cycler 480 (Roche). The expression card will be customised for the study, including the genes cxcl9/10, cav-1, rhoj, cdh5, cd96, tnfsf8, il-21r, vcam, klrk1
| Study group | Role | What they receive |
|---|---|---|
| Patients with post-OLT rejection | Experimental | The patient will be enrolled in a single visit, as per standard of care, clinical and general data will be collected and the biopsy will be performed Receives: Diagnostic Test: Molecular diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of genes associated with acute rejection liver transplant.
A panel of acute rejection indicator genes (both humoral and cell-mediated) will be selected from Scientific literature and applied to biological material from biopsies
Measured: At the time of biopsy, up to 6 months
Secondary outcomes (2)
Identification of genes associated with the diagnosis of acute humoral rejection
A panel of acute rejection indicator genes applied to biological material from biopsies
Measured: At the time of biopsy, up to 6 months
Identification of genes associated with the diagnosis of acute cell-mediated rejection
A panel of acute rejection indicator genes applied to biological material from biopsies
Measured: At the time of biopsy, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start17 Oct 2024
- Primary completion2 May 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rejection; Transplant, LiverStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Malvi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734013
- Sponsor's protocol ID
- OLTpanel_2024
- Other IDs
- 2023.0189
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptomics as an Aid in the Histological Diagnosis of Acute Rejection After Liver Transplantation
- ClinicalTrials.gov ID
- NCT06734013
- Acronym / sponsor ID
- OLTpanel_2024
- Conditions
- Rejection; Transplant, Liver
- Keywords
- Liver transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 Dec 2024 (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.
The primary objective of this exploratory study is to identify genes associated with acute rejection in liver transplant patients. To this end, a panel of acute rejection indicator genes (both humoral and cell-mediated) will be selected from results published in the literature and applied to biological material derived from biopsies. The secodnary objective is to identify genes associated with the diagnosis of humoral acute rejection and those associated with the diagnosis of cell-mediated acute rejection.
Detailed description
The possibility of introducing molecular diagnostics in support of histological and clinical diagnostics (still not routinely applied today but recommended by the most recent guidelines) will result in faster and more precise diagnostics, capable of highlighting early activation of cellular signals related to rejection in the absence yet of a frank clinical and histological picture. This will lead to a better diagnostic stratification of these patients, with the possibility of rationalising the choice of therapy.
AIMS: The primary objective of this exploratory study is to identify genes associated with acute rejection in liver transplant patients. To this end, a panel of acute rejection indicator genes (both humoral and cell-mediated) will be selected from published results in the literature and applied to biological material derived from biopsies. The secodnary objective is to identify genes associated with the diagnosis of humoral acute rejection and those associated with the diagnosis of cell-mediated acute rejection.
ENDPOINT/S: diagnostic (No of cases) of acute rejection; possible specific diagnosis of acute cell-mediated and humoral rejection.
STUDY DESIGN: The study is single-centre, observational, tissue-based, cross-sectional, exploratory, retrospective and prospective. Approximately 40 patients are expected to be enrolled, 20 retrospective and 20 prospective. All patients will be treated according to clinical practice: clinical and histological data will be collected in pseudonymous form. Routine histological and immunohistochemical investigations as well as RT-PCR analysis will be performed on the biopsy tissue (FFPE material). To assess the diagnostic sensitivity with regard to rejection status, and for panel development, a retrospective cohort of consecutive cases with acute rejection will be enrolled; for the prospective cohort, consecutive patients requiring liver biopsy for diagnostic indications will be enrolled.
STUDY POPULATION: The study will enrol patients undergoing OLT who require a liver biopsy for diagnostic indications. There is no restriction of sex or underlying pathology. Retrospective case enrolment is planned within the first 6 months of 2024. Prospective case enrolment will take place during 2024. Patients will be enrolled at the U.O. of Internal Medicine for the Treatment of Severe Organ Failures, IRCCS - Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola, where the biopsy will be performed as standard of care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with post-OLT rejection | Experimental | Diagnostic Test: Molecular diagnosticThe patient will be enrolled in a single visit, as per standard of care, clinical and general data will be collected and the biopsy will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular diagnosticRNA will be analysed using a Real-Time PCR expression card (TaqMan Real-Time PCR assay technology - Thermo Fisher Scientific). The analysis will be performed using a Real-Time Light Cycler 480 (Roche). The expression card will be customised for the study, including the genes cxcl9/10, cav-1, rhoj, cdh5, cd96, tnfsf8, il-21r, vcam, klrk1 | Diagnostic test | Patients with post-OLT rejection |
Primary outcome
Identification of genes associated with acute rejection liver transplant.
Time frame: At the time of biopsy, up to 6 months
A panel of acute rejection indicator genes (both humoral and cell-mediated) will be selected from Scientific literature and applied to biological material from biopsies
2 secondary outcomes
Identification of genes associated with the diagnosis of acute humoral rejection
Time frame: At the time of biopsy, up to 6 months
Identification of genes associated with the diagnosis of acute cell-mediated rejection
Time frame: At the time of biopsy, up to 6 months
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 16 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Deborah Malvi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular diagnostic in people with Rejection; Transplant, Liver, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site 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 3 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Deborah Malvi, MD (0512143761, deborah.malvi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of genes associated with acute rejection liver transplant. (time frame: At the time of biopsy, up to 6 months). 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 16 Dec 2024.