Clinical trial · Observational
San Raffaele Registry on Liver Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver and Intrahepatic Biliary Tract Cancer | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with diagnosis of primary liver cancer
- description
- Patients with diagnosis of hepatocellular carcinoma or biliary tract cancer presenting to IRCCS Ospedale San Raffaele will be included
Primary outcomes (1)
- measure
- To collect clinical data from patients with primary liver disease
- timeFrame
- From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years
- description
- Collection of all clinical data from patients with primary liver disease
Secondary outcomes (4)
- measure
- To seek correlation between clinical and molecular data with PFS outcome
- timeFrame
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. ≥18 years of age. 3. Patients diagnosed with any subtype of biliary tract cancer (i.e. iCCA, pCCA, dCCA or GBC) at every stage and with all therapeutic indications. 4. 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).
References
Publications (0)
Data not yet available