San Raffaele Registry on Liver Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 4,000
- Locations
- 1
- Primary Endpoint
- To collect clinical data from patients with primary liver disease
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •1. Patients without diagnosis of hepatocellular carcinoma or biliary tract cancer (BTC).
Outcomes
Primary Outcomes
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
- 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)
Investigators
Andrea Casadei Gardini
Clinical Professor
IRCCS San Raffaele