San Raffaele Registry on Liver Cancer

NCT07704489 | Recruiting

• 1 other identifier: SR Liver Cancer Registry
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver and Intrahepatic Biliary Tract Cancer

Keywords

registry of primary liver cancer; hepatocellular carcinoma and biliary tract carcinom

Outcome Measures

Primary Outcomes (1)

• To collect clinical data from patients with primary liver disease

  Collection of all clinical data from patients with primary liver disease

  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

  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

  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

  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

  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

Other Outcomes (3)

• To seek potential immunological biomarker

  Baseline, 3, 6, 9, 12 months, and at disease progression (PD)

• To seek potential genetic biomarker

  Baseline, 3, 6, 9, 12 months, and at disease progression (PD)

• To seek potential histological biomarker

  Baseline, 3, 6, 9, 12 months, and at disease progression (PD)

Study Arms (1)

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

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

Patients with diagnosis of primary liver cancer (hepatocellular carcinoma or biliary tract cancer) presenting to IRCCS Ospedale San Raffaele

You may qualify if:

• 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.

You may not qualify if:

• \. Patients without diagnosis of hepatocellular carcinoma or biliary tract cancer (BTC).

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 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

Central Study Contacts

Andrea Casadei Gardini, Medical Oncologist

CONTACT

+390226437627; CasadeiGardini.Andrea@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 15, 2026
• Study Start: October 20, 2021
• Primary Completion (Estimated): October 1, 2050
• Study Completion (Estimated): October 1, 2050
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

IT (1)