Liver and Intrahepatic Biliary Tract CancerNCT07704489
San Raffaele Registry on Liver Cancer
An observational study of Liver and Intrahepatic Biliary Tract Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a Retrospective and Prospective Observational Single-Center Study. The purpose is to collect all data to generate a registry of primary liver cancer (hepatocellular carcinoma and biliary tract carcinoma) of patients accessing to San Raffaele Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver and Intrahepatic Biliary Tract Cancer
- How many people
- 4,000 participants
- Where
- 1 siteItaly
- Study dates
- 20 Oct 2021to Oct 2050
- 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: Patients with diagnosis of primary liver cancer (hepatocellular carcinoma or biliary tract cancer) presenting to IRCCS Ospedale San Raffaele
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study. However, concerning the retrospective cohort, the large sample sizes needed and considering that the disease involved in this study affects elderly subjects with co-morbidities and presents a significant mortality rate based on the stage of the disease, deceased and untraceable patients will also be included.
- ≥18 years of age.
- Patients diagnosed with any subtype of biliary tract cancer (i.e. iCCA, pCCA, dCCA or GBC) at every stage and with all therapeutic indications.
- Patients diagnosed with hepatocellular carcinoma at every stage and treated with all therapeutic options.
Who cannot join
- 1. Patients without diagnosis of hepatocellular carcinoma or biliary tract cancer (BTC).
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 Ospedale San Raffaele
Milan
Andrea Casadei Gardini, Medical Oncologist, +390226437627, CasadeiGardini.Andrea@hsr.it
About this study
This is a Retrospective and Prospective Observational Single-Center Study. The purpose is to collect all data to generate a registry of primary liver cancer (hepatocellular carcinoma and biliary tract carcinoma) of patients accessing to San Raffaele Hospital. An additional purpose is to identify novel biomarkers to better manage primary liver cancer patients, for whom additional biological samples will be collected.
A total of 4000 patients will be enrolled; for the prospective cohort: from protocol approval to the achievement of the last planned patients in the prospective cohort (2000 patients). The retrospective cohort will start from the year 2000.
Patients will be followed for 5 years of follow-up.
Read the detailed description
The object of the study is to collect all data from patients with primary liver diseases (hepatocellular carcinoma or BTC), investigating any correlation with clinical and/or molecular characteristics. As exploratory analysis, the project will explore the possible identification of any immunological, genetic, histological, cellular, molecular, and/or microbiological biomarker that could support patients' management.
Data collection of enrolled patients will cover all initial information regarding patient disease characteristics and profiling and all follow-up data available, included any data generated by other hospitals but referring to the disease studied. As this is an observational study, there will be no modification to any existing treatment pathways for patients. The only additional procedures are the collection of some biological samples at different timepoints (baseline, 3, 6, 9, 12 months and at disease progression):
- Additional blood volumes (approximately 30 mL) to collect during routinary blood exams
- Saliva
- Stool
Moreover, also tumor tissue will be investigated for exploratory analysis. In particular, tumor tissue collected according to normal clinical practice (baseline, eventually surgery, and/or re-biopsy), if still available after diagnostic purpose, will be analyzed to seek novel biomarkers. Additionally to FFPE archivial tumor tissue, exceeding fresh tumor tissue from diagnostic purpose, may be stored in other media other than paraffin (for example OTC).
A total of 4000 patients will be enrolled; for the prospective cohort: from protocol approval to the achievement of the last planned patients in the prospective cohort (2000 patients). The retrospective cohort will start from the year 2000.
Patients will be followed for 5 years of follow-up.
- Keywords
- registry of primary liver cancer, hepatocellular carcinoma and biliary tract carcinom
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diagnosis of primary liver cancer | Patients with diagnosis of hepatocellular carcinoma or biliary tract cancer presenting to IRCCS Ospedale San Raffaele will be included |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect clinical data from patients with primary liver disease
Collection of all clinical data from patients with primary liver disease
Measured: From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years
Secondary outcomes (4)
To seek correlation between clinical and molecular data with PFS outcome
-Progression-free survival (PFS), defined as the time from the start of each treatment line to the first documented disease progression or death from any cause, whichever occurs first, according to RECIST version 1.1. PFS will be assessed separately for each treatment line received by the patien
Measured: From date of start of each treatment line until the date of first documented progression or date of death from any cause, assessed up to 12 months. Tumor assessments will be performed in accordance with clinical practice
To seek correlation between clinical and molecular data with OS outcome
Overall survival, defined as the time from diagnosis to death from any cause.
Measured: From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years
To seek correlation between clinical and molecular data with Toxicity outcome
Frequency and severity of adverse events related to treatment, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v.6.
Measured: From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years
To seek correlation between clinical and molecular data with DFS outcome
DFS: Time from complete response or radical surgery to disease recurrence or death from any cause
Measured: From date of surgery or complete response until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 5 years. Tumor assessments will be performed in accordance with clinical practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start20 Oct 2021
- Primary completionOct 2050 (estimated)
- Study completionOct 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver and Intrahepatic Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Casadei Gardini, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704489
- Sponsor's protocol ID
- SR Liver Cancer Registry
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- San Raffaele Registry on Liver Cancer
- ClinicalTrials.gov ID
- NCT07704489
- Acronym / sponsor ID
- SR Liver Cancer Registry
- Keywords
- registry of primary liver cancer, hepatocellular carcinoma and biliary tract carcinom
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- Oct 2050 (estimated)
- Study completion
- Oct 2050 (estimated)
- First posted
- 15 Jul 2026 (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 a Retrospective and Prospective Observational Single-Center Study. The purpose is to collect all data to generate a registry of primary liver cancer (hepatocellular carcinoma and biliary tract carcinoma) of patients accessing to San Raffaele Hospital. An additional purpose is to identify novel biomarkers to better manage primary liver cancer patients, for whom additional biological samples will be collected.
A total of 4000 patients will be enrolled; for the prospective cohort: from protocol approval to the achievement of the last planned patients in the prospective cohort (2000 patients). The retrospective cohort will start from the year 2000.
Patients will be followed for 5 years of follow-up.
Detailed description
The object of the study is to collect all data from patients with primary liver diseases (hepatocellular carcinoma or BTC), investigating any correlation with clinical and/or molecular characteristics. As exploratory analysis, the project will explore the possible identification of any immunological, genetic, histological, cellular, molecular, and/or microbiological biomarker that could support patients' management.
Data collection of enrolled patients will cover all initial information regarding patient disease characteristics and profiling and all follow-up data available, included any data generated by other hospitals but referring to the disease studied. As this is an observational study, there will be no modification to any existing treatment pathways for patients. The only additional procedures are the collection of some biological samples at different timepoints (baseline, 3, 6, 9, 12 months and at disease progression):
- Additional blood volumes (approximately 30 mL) to collect during routinary blood exams
- Saliva
- Stool
Moreover, also tumor tissue will be investigated for exploratory analysis. In particular, tumor tissue collected according to normal clinical practice (baseline, eventually surgery, and/or re-biopsy), if still available after diagnostic purpose, will be analyzed to seek novel biomarkers. Additionally to FFPE archivial tumor tissue, exceeding fresh tumor tissue from diagnostic purpose, may be stored in other media other than paraffin (for example OTC).
A total of 4000 patients will be enrolled; for the prospective cohort: from protocol approval to the achievement of the last planned patients in the prospective cohort (2000 patients). The retrospective cohort will start from the year 2000.
Patients will be followed for 5 years of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diagnosis of primary liver cancer | – | –Patients with diagnosis of hepatocellular carcinoma or biliary tract cancer presenting to IRCCS Ospedale San Raffaele will be included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of primary liver cancer (hepatocellular carcinoma or biliary tract cancer) presenting to IRCCS Ospedale San Raffaele
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study. However, concerning the retrospective cohort, the large sample sizes needed and considering that the disease involved in this study affects elderly subjects with co-morbidities and presents a significant mortality rate based on the stage of the disease, deceased and untraceable patients will also be included.
- ≥18 years of age.
- Patients diagnosed with any subtype of biliary tract cancer (i.e. iCCA, pCCA, dCCA or GBC) at every stage and with all therapeutic indications.
- Patients diagnosed with hepatocellular carcinoma at every stage and treated with all therapeutic options.
Key exclusion criteria (1 listed)
- 1. Patients without diagnosis of hepatocellular carcinoma or biliary tract cancer (BTC).
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
To collect clinical data from patients with primary liver disease
Time frame: From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years
Collection of all clinical data from patients with primary liver disease
4 secondary outcomes
To seek correlation between clinical and molecular data with PFS outcome
Time frame: From date of start of each treatment line until the date of first documented progression or date of death from any cause, assessed up to 12 months. Tumor assessments will be performed in accordance with clinical practice
To seek correlation between clinical and molecular data with OS outcome
Time frame: From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years
To seek correlation between clinical and molecular data with Toxicity outcome
Time frame: From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years
To seek correlation between clinical and molecular data with DFS outcome
Time frame: From date of surgery or complete response until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 5 years. Tumor assessments will be performed in accordance with clinical practice
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 15 Jul 2026.
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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.
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 Liver and Intrahepatic Biliary Tract Cancer, run by IRCCS San Raffaele 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 4 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 15 Jul 2026. 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 Andrea Casadei Gardini, Medical Oncologist (+390226437627, CasadeiGardini.Andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To collect clinical data from patients with primary liver disease (time frame: From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years). 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 15 Jul 2026.