Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05730686
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-16
First Post:
2023-02-07
Brief Title:
FibroLamellar Carcinoma an International Registry Study
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
FibroLamellar Carcinoma an International Registry Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLiCIR
Brief Summary:
Fibrolamellar Hepatocellular Carcinoma FLC is a rare 005 per 100000 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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None