Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients

NCT06774768 | Not Yet Recruiting

• 2 other identifiers: DAREPNC0000002 3000435
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

This is an observational, low risk tissue based, non-pharmacological, retrospective-prospective study for adults heart and liver transplant patients, related to IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO). This clinical study is part of the national multicentric project DARE. The project has the wide overarching aim to develop digital solutions for personalized healthcare.

Conditions

Artificial Intelligence (AI); Hepatocellular Carcinoma (HCC); Heart Transplantation; Liver Transplantation; Machine Learning; Major Cardiovascular Event

Outcome Measures

Primary Outcomes (4)

• Infection

  Infection, defined as systemic or organ-specific syndrome characterized by evidence of inflammatory response, abnormal organ function, and need for intravenous antimicrobial treatment, with or without microbiological isolate.

  4 years

• Major Cardiovascular Event (MACE)

  Major Cardiovascular Event (MACE) defined as, fatal or non-fatal myocardial infarction, ischemic or hemorrhagic stroke, admission for heart failure, new onset arrhythmia, new onset symptoms for peripheral artery diseases

  4 years

• New onset malignancy

  New onset malignancy, defined as hematopoietic or solid malignant neoplasm, developing after transplantation

  4 years

• Chronic graft dysfunction

  Chronic graft dysfunction; in HTX recipients defined as onset of one or more of the following: CAV grade 2 or greater as diagnosed by standard of care coronary angiography; diffuse fibrosis with signs of diastolic or systolic left ventricle dysfunction. In LTX we define chronic graft dysfunction as progressive fibrosis, cholestasis and reduced protein synthesis, portal hypertension.

  4 years

Secondary Outcomes (1)

• ML-Scores as Surrogate Endpoints

  4 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the retrospective phase we will include all patients receiving heart or liver transplantation between January 2008 and December 2020 and surviving at least 6 months after surgery. In the prospective phase we will consider for enrolment all patients with heart or liver transplantation actively on follow-up at IRCCS AOUBO from January 2024 and January 2026.

You may qualify if:

• Surviving at least 6 months after surgery Receiving at least one outpatient clinical assessment, comprising clinical evaluation, standard laboratory tests, and graft ultrasound Older than 18 years old

You may not qualify if:

• Prospective cohort

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS - Azienda ospedaliero-universitaria di Bologna

Bologna, 40138, Italy

Location

IRCCS - Azienda ospedaliero-universitaria di Bologna

Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

All enrolled patients will receive additional blood sampling at enrolment (approximately 20 ml) and then at 6 and 12 month of follow-up, during a venopucture performed for the standard laboratory follow-up. Additional samples will be used for assaying a comprehensive array of biomarkers that may provide information regarding immune system activity (T-regs, circulating nanovescicles, microRNA), graft injury (donor-derived cell free DNA), and susceptibility to infection (Quantiferon Monitor; Torque Teno Virus).

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Luciano Potena, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciano Potena, MD

CONTACT

0512143725; scompenso.trapiantocuore@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: January 30, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 14, 2025

Record last verified: 2024-12

Locations

IT (2)