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

NCT06774690 | Recruiting

• 1 other identifier: IAT for liver cancer
• Study Type: observational
• Target: 3,300
• Locations: 1 country
• Sites: 1

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.

Conditions

HCC - Hepatocellular Carcinoma; Cholangiocarcinoma Cancer

Outcome Measures

Primary Outcomes (3)

• Type and size of the injury

  Type and size of the injury

  From enrollment to the end of treatment at 9 years

• Radiological response to therapy

  Radiological response to therapy

  From enrollment to the end of treatment at 9 years

• Post treatment complications

  Post treatment complications

  From enrollment to the end of treatment at 9 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be selected from patients that are followed at Radiology Department of IRCCS Azienda Ospedaliero-Universitaria hospital in the city of Bologna.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

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

• Cristina Mosconi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Mosconi, MD

CONTACT

0039 3498496325; cristina.mosconi@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 9 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: April 21, 2021
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: January 14, 2025

Record last verified: 2024-10

Locations

IT (1)