| NCT ID | NCT07704489 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Liver and Intrahepatic Biliary Tract Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2021-10-20 |
| Primary Completion | 2050-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,000 participants in total. It began in 2021-10-20 with a primary completion date of 2050-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07704489 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver and Intrahepatic Biliary Tract Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07704489 currently recruiting?
Yes, NCT07704489 is actively recruiting participants. Contact the research team at CasadeiGardini.Andrea@hsr.it for enrollment information.
Where is the NCT07704489 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07704489 clinical trial?
NCT07704489 is sponsored by IRCCS San Raffaele. The trial plans to enroll 4,000 participants.
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