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NCT Number: NCT07704489

San Raffaele Registry on Liver Cancer

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.

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Key information

Conditions

Liver and Intrahepatic Biliary Tract Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, Italy

Location status: Recruiting

Location contact

Andrea Casadei Gardini, Medical Oncologist

CONTACT

[email protected]

+390226437627

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    -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

  2. 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

    Overall survival, defined as the time from diagnosis to death from any cause.

  3. 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

    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.

  4. 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

    DFS: Time from complete response or radical surgery to disease recurrence or death from any cause

Other outcomes

  1. To seek potential immunological biomarker

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

    Changes in immunological biomarkers will be assessed through the evaluation of soluble factors (such as cytokines) and immunophenotype of circulating and tumor-resident immune cells.

  2. To seek potential genetic biomarker

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

    Prevalence and type of somatic genetic alterations in tumor tissue assessed with Next-Generation Sequencing (NGS).

  3. To seek potential histological biomarker

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

    Histological tumor features will be assessed using high-throughput approaches, including multiplexed immunohistochemistry (IHC), to explore novel prognostic and/or predictive biomarkers.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Casadei Gardini, Medical Oncologist

CONTACT

[email protected]

+390226437627

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2021
Primary completion
2050
Study completion
2050
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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