FibroLamellar Carcinoma: an International Registry Study

NCT ID: NCT05730686

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-15

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Fibrolamellar Cancer of the Liver

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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Registry of Therapy of patient's diagnosed with FibroLamellar

Registry of Therapy of patient's diagnosed with FibroLamellar

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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22HH8014

Identifier Type: -

Identifier Source: org_study_id

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