San Raffaele Registry on Liver Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Patients with diagnosis of primary liver cancer (hepatocellular carcinoma or biliary tract cancer) presenting to IRCCS Ospedale San Raffaele
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
4,000 Participants
are grouped into 1 trial groupGroup A: Patients with diagnosis of primary liver cancer
Trial outcomes
Primary outcomes
1
To 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 yearsSecondary outcomes
1
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 practice2
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 years3
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 years4
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 practiceOther outcomes
1
To seek potential immunological biomarker
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.
Time frame
Baseline, 3, 6, 9, 12 months, and at disease progression (PD)2
To seek potential genetic biomarker
Prevalence and type of somatic genetic alterations in tumor tissue assessed with Next-Generation Sequencing (NGS).
Time frame
Baseline, 3, 6, 9, 12 months, and at disease progression (PD)3
To seek potential histological biomarker
Histological tumor features will be assessed using high-throughput approaches, including multiplexed immunohistochemistry (IHC), to explore novel prognostic and/or predictive biomarkers.
Time frame
Baseline, 3, 6, 9, 12 months, and at disease progression (PD)Sponsors and contacts
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Source ClinicalTrials.gov