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.
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 Type
OBSERVATIONAL
Enrollment
4,000
IRCCS Ospedale San Raffaele
Milan, Italy
RECRUITINGTo collect clinical data from patients with primary liver disease
Collection of all 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
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
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
Overall survival, defined as the time from diagnosis to death from any cause.
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
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.
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
DFS: Time from complete response or radical surgery to disease recurrence or death from any cause
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
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