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Trial Title:
FibroLamellar Carcinoma: an International Registry Study
NCT ID:
NCT05730686
Condition:
Fibrolamellar Cancer of the Liver
Conditions: Official terms:
Liver Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Procedure
Intervention name:
Registry of Therapy of patient's diagnosed with FibroLamellar
Description:
Registry of Therapy of patient's diagnosed with FibroLamellar
Summary:
Fibrolamellar Hepatocellular Carcinoma (FLC) is a rare (0.05 per 100,000) subtype of
primary liver cancer which predominantly affects younger patients, median age of
diagnosis 22-23 years. In patients with advanced stage disease the prognosis is poor, and
even with aggressive surgery the 5 year survival is less than 50%.
Due to the very low incidence of FLC clinical trials are limited, and as these patients
are excluded from most clinical trials there is a lack of consensus on the optimal
systemic therapy to employ in this population group.
There are a number of chemotherapy compounds that have been investigated although these
are single-institutional case series and/or registry-based studies. The majority of
published registry studies are based in the United States hence it is important to
describe the patterns of treatment in Europe which has different regulatory approvals for
access to therapeutics. Our aim is to run a European multisite registry study detailing
the clinical course of >100 patients with FLC that have received systemic therapy.
Criteria for eligibility:
Study pop:
Prospective patients will be recruited from clinic
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Histologic confirmed diagnosis of FLC
- Written informed consent will be required for the prospective cohort
- Adults of >18 years of age
Exclusion Criteria:
- Any non- histologic confirmed diagnosis of FLC
- Participants with insufficient clinical/ follow up data
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
February 15, 2023
Completion date:
February 28, 2025
Lead sponsor:
Agency:
Imperial College London
Agency class:
Other
Source:
Imperial College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05730686
