Alcohol Related Liver DiseaseNCT06749990
Risk and Protective Factors for Relapse to Alcohol Use in Patients With Liver Disease Undergoing Liver Transplantation
An observational study of Alcohol Related Liver Disease and Orthotopic Liver Transplantation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This is an observational, monocentric study, consisting of both a retrospective and a prospective component. The aim of the study is to identify risk and protective factors for alcohol relapse in patients with alcohol-related liver disease (ARLD) who have undergone orthotopic liver transplantation (OLT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Related Liver Disease, Orthotopic Liver Transplantation
- How many people
- 320 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2024to 31 Dec 2030
- 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: The patients in the retrospective cohort include those diagnosed with ARLD and exotoxicity-related components who underwent liver transplantation and were followed at the Internal Medicine Department for the treatment of severe organ failure at IRCCS AOUBO between 01/01/2017 and 31/12/2022. The patients in the prospective cohort are those diagnosed with ARLD or with exotoxicity-related etiologies who are referred to the Internal Medicine Department for the treatment of severe organ failure.
Who may be able to join
- Patients who have signed the informed consent
- Candidates for liver transplantation due to liver disease with alcohol-related etiology (either mono- or multifactorial)
- For the retrospective part: patients who underwent OLT for ARLD during the time frame 2017-2022
Who cannot join
- Major psychopathologies and active psychoses
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
Maria Cristina Morelli, 0512144248, mariacristina.morelli@aosp.bo.it
About this study
Official title: Risk and Protective Factors for Relapse to Alcohol Use in Patients With Alcohol-related Liver Disease and Undergoing Orthotopic Liver Transplantation
This is an observational, monocentric study, consisting of both a retrospective and a prospective component. The aim of the study is to identify risk and protective factors for alcohol relapse in patients with alcohol-related liver disease (ARLD) who have undergone orthotopic liver transplantation (OLT).
Read the detailed description
For the retrospective part of the study, clinical data will be collected and analyzed from patients diagnosed with ARLD and with components of exotoxicity who underwent liver transplantation in the past five years. This data will be obtained from patient medical records, including results from laboratory tests and multidisciplinary outpatient consultations conducted as part of routine clinical practice.
The prospective phase of the study will involve the consecutive enrollment of patients diagnosed with ARLD or with exotoxicity-related etiological components who are undergoing liver transplantation at the IRCCS AOUBO. Four patient assessment points are planned, which will take place during routine follow-up visits already scheduled as part of the patient's care pathway. During these visits, data will be collected on the patient's medical history, laboratory and/or histological results, as well as diagnostic and surgical information. Additionally, through the administration of clinical questionnaires, data will be gathered on the patient's psychiatric-psychological status, history of exotoxicity, and psychosocial background.
What is being measured
The primary outcome is the main question the study is designed to answer.
alcohol relapse rate
To describe the population undergoing liver transplantation with a diagnosis of ARLD and exotoxicity-related components in terms of alcohol relapse rate
Measured: 7 years
alcohol recurrence rate
To describe the population undergoing liver transplantation with a diagnosis of ARLD and exotoxicity-related components in terms of alcohol recurrence rate
Measured: 7 years
Clinical data to assess the risk of alcohol relapse
Collection of clinical data on liver disease through routine visits to assess the risk of alcohol relapse at 12 months post-OLT
Measured: 7 years
psychiatric evaluation to assess the risk of alcohol relapse
Administration of a clinimetric assessment composed of psychometric, self-assessment tests, already validated and widely used in the literature
Measured: 7 years
Secondary outcomes (2)
Impact of alcohol relapse/recurrence on liver transplant outcomes
To assess the impact of alcohol relapse/recurrence on liver transplant outcomes.
Measured: 7 years
Identifying Risk and Protective Factors for Alcohol Relapse
To identify potential risk and protective factors for alcohol relapse and, consequently, to develop a multiparametric/multimodal operational model for evaluating candidates for liver transplantation
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 posted27 Dec 2024
- Study start9 Jan 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Related Liver DiseaseStudies 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
- Other
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Cristina Morelli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749990
- Sponsor's protocol ID
- RICADUTA
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk and Protective Factors for Relapse to Alcohol Use in Patients With Alcohol-related Liver Disease and Undergoing Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT06749990
- Acronym / sponsor ID
- RICADUTA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 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.
This is an observational, monocentric study, consisting of both a retrospective and a prospective component. The aim of the study is to identify risk and protective factors for alcohol relapse in patients with alcohol-related liver disease (ARLD) who have undergone orthotopic liver transplantation (OLT).
Detailed description
For the retrospective part of the study, clinical data will be collected and analyzed from patients diagnosed with ARLD and with components of exotoxicity who underwent liver transplantation in the past five years. This data will be obtained from patient medical records, including results from laboratory tests and multidisciplinary outpatient consultations conducted as part of routine clinical practice.
The prospective phase of the study will involve the consecutive enrollment of patients diagnosed with ARLD or with exotoxicity-related etiological components who are undergoing liver transplantation at the IRCCS AOUBO. Four patient assessment points are planned, which will take place during routine follow-up visits already scheduled as part of the patient's care pathway. During these visits, data will be collected on the patient's medical history, laboratory and/or histological results, as well as diagnostic and surgical information. Additionally, through the administration of clinical questionnaires, data will be gathered on the patient's psychiatric-psychological status, history of exotoxicity, and psychosocial background.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients in the retrospective cohort include those diagnosed with ARLD and exotoxicity-related components who underwent liver transplantation and were followed at the Internal Medicine Department for the treatment of severe organ failure at IRCCS AOUBO between 01/01/2017 and 31/12/2022. The patients in the prospective cohort are those diagnosed with ARLD or with exotoxicity-related etiologies who are referred to the Internal Medicine Department for the treatment of severe organ failure.
Key inclusion criteria (3 listed)
- Patients who have signed the informed consent
- Candidates for liver transplantation due to liver disease with alcohol-related etiology (either mono- or multifactorial)
- For the retrospective part: patients who underwent OLT for ARLD during the time frame 2017-2022
Key exclusion criteria (1 listed)
- Major psychopathologies and active psychoses
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
alcohol relapse rate
Time frame: 7 years
To describe the population undergoing liver transplantation with a diagnosis of ARLD and exotoxicity-related components in terms of alcohol relapse rate
alcohol recurrence rate
Time frame: 7 years
To describe the population undergoing liver transplantation with a diagnosis of ARLD and exotoxicity-related components in terms of alcohol recurrence rate
Clinical data to assess the risk of alcohol relapse
Time frame: 7 years
Collection of clinical data on liver disease through routine visits to assess the risk of alcohol relapse at 12 months post-OLT
psychiatric evaluation to assess the risk of alcohol relapse
Time frame: 7 years
Administration of a clinimetric assessment composed of psychometric, self-assessment tests, already validated and widely used in the literature
2 secondary outcomes
Impact of alcohol relapse/recurrence on liver transplant outcomes
Time frame: 7 years
Identifying Risk and Protective Factors for Alcohol Relapse
Time frame: 7 years
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 27 Dec 2024.
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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.
Maria Cristina Morelli, 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?
An observational study of Alcohol Related Liver Disease and Orthotopic Liver Transplantation, 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 27 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 Maria Cristina Morelli, MD (0512144248, mariacristina.morelli@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alcohol relapse rate (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 27 Dec 2024.