HCC - Hepatocellular CarcinomaNCT06774690
Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study
An observational study of HCC - Hepatocellular Carcinoma and Cholangiocarcinoma Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Cholangiocarcinoma Cancer
- How many people
- 3,300 participants
- Where
- 1 siteItaly
- Study dates
- 21 Apr 2021to Apr 2030
- How long will I take part?
- 9 Years
- 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
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- shunt of gastro intestinal arteries that cannot be embolized
- metastasis spread outside of the liver
- liver failure
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
Cristina Mosconi, MD, 0039 3498496325, cristina.mosconi@aosp.bo.it
About this study
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.
Read the 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.
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Type and size of the injury
Type and size of the injury
Measured: From enrollment to the end of treatment at 9 years
Radiological response to therapy
Radiological response to therapy
Measured: From enrollment to the end of treatment at 9 years
Post treatment complications
Post treatment complications
Measured: From enrollment to the end of treatment at 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start21 Apr 2021
- Primary completionMar 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies 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
- 3,300 participants (estimated)
- Target duration
- 9 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Mosconi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774690
- Sponsor's protocol ID
- IAT for liver cancer
- Status last verified
- Oct 2024
- First submitted
- 9 Jan 2025
- Last updated
- 14 Jan 2025
- 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study
- ClinicalTrials.gov ID
- NCT06774690
- Acronym / sponsor ID
- IAT for liver cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 14 Jan 2025 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 9 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- diagnosis of Hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA) and clinical indication to receive or have already received one of the following treatments:
- Age over 18
- To give informed consent
Key exclusion criteria (3 listed)
- shunt of gastro intestinal arteries that cannot be embolized
- metastasis spread outside of the liver
- liver failure
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
Type and size of the injury
Time frame: From enrollment to the end of treatment at 9 years
Type and size of the injury
Radiological response to therapy
Time frame: From enrollment to the end of treatment at 9 years
Radiological response to therapy
Post treatment complications
Time frame: From enrollment to the end of treatment at 9 years
Post treatment complications
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 14 Jan 2025.
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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.
Cristina Mosconi, 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 HCC - Hepatocellular Carcinoma and Cholangiocarcinoma Cancer, 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 7 inclusion and 3 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 14 Jan 2025. 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 Cristina Mosconi, MD (0039 3498496325, cristina.mosconi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type and size of the injury (time frame: From enrollment to the end of treatment at 9 years). The study lists 3 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 14 Jan 2025.