Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study

NCT ID: NCT06774690

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2030-04-30

Brief Summary

The goal of this observational study is to learn what are the best conditions that will give a positive outcome to men and women that receive a intra arterial therapy (IAT) for primary liver cancer.

Intra arterial therapies are radiologic procedures that block liver cancer blood supply.

The researchers will collect the data of participants located in the Radiology department in "IRCCS Azienda Ospedaliera Universitaria" Hospital in Bologna and will study clinic and radiological traits to understand which is the best case scenario for a optimal treatment response.

Detailed Description

This study is non profit, observational, retrospective, prospective and single institution.

The researchers will do a retrospective and prospective data collection and analyze the results. They will examine the radiological images (CT scan and RM) to assess the type and size of the cancer, track how the disease responds to treatments, identify possible complications.

There are no drugs involved and all the intra arterial therapies are performed within the routine clinical-care path.

• For the retrospective phase the researchers will analyze radiological image of the participants that received a intra arterial therapy from the 1st of January 2009. It's expected to enroll around 2000 participants.
• For the prospective phase the researchers will enroll for 5 years eligible participants that will receive a intra arterial therapy. Participants will go through a follow up every three months for the duration of the whole study. It is expected to enroll around 1300 participants.

Conditions

HCC - Hepatocellular Carcinoma; Cholangiocarcinoma Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• diagnosis of Hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA) and clinical indication to receive or have already received one of the following treatments:

• Trans-arterial embolization (TAE),
• Transarterial chemoembolization (TACE),
• Transarterial radioembolization (TARE)
• Drug-eluting beads chemoembolization (DEB-TACE)
• Age over 18
• To give informed consent

Exclusion Criteria

• shunt of gastro intestinal arteries that cannot be embolized
• metastasis spread outside of the liver
• liver failure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristina Mosconi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Cristina Mosconi, MD

Role: CONTACT

cristina.mosconi@aosp.bo.it

0039 3498496325

Facility Contacts

Cristina Mosconi, MD

Role: primary

cristina.mosconi@aosp.bo.it

0039 3498496325

Other Identifiers

IAT for liver cancer

Identifier Type: -

Identifier Source: org_study_id