Fibrolamellar Cancer of the LiverFLiCIRNCT05730686
FibroLamellar Carcinoma: an International Registry Study
An observational study of Fibrolamellar Cancer of the Liver, run by Imperial College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrolamellar Cancer of the Liver
- What is being tested?
- Registry of Therapy of patient's diagnosed with FibroLamellar
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective patients will be recruited from clinic
Who may be able to join
- Histologic confirmed diagnosis of FLC
- Written informed consent will be required for the prospective cohort
- Adults of >18 years of age
Who cannot join
- Any non- histologic confirmed diagnosis of FLC
- Participants with insufficient clinical/ follow up data
About this study
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.
- Conditions
- Fibrolamellar Cancer of the Liver
- Being tested
- Registry of Therapy of patient's diagnosed with FibroLamellar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registry of Therapy of patient's diagnosed with FibroLamellarProcedure or surgery
Registry of Therapy of patient's diagnosed with FibroLamellar
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the natural history and clinical outcomes of patients with Fibrolamellar carcinoma of the liver
The following data will be outcomes of interest in this study: treatments received including compliance and tolerability, survival (overall and progress free survival), clinicopathological outcomes. Survival outcomes, response rates
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrolamellar Cancer of the LiverStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730686
- Sponsor's protocol ID
- 22HH8014
- Acronym
- FLiCIR
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FibroLamellar Carcinoma: an International Registry Study
- ClinicalTrials.gov ID
- NCT05730686
- Acronym / sponsor ID
- FLiCIR / 22HH8014
- Conditions
- Fibrolamellar Cancer of the Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective patients will be recruited from clinic
Key inclusion criteria (3 listed)
- Histologic confirmed diagnosis of FLC
- Written informed consent will be required for the prospective cohort
- Adults of >18 years of age
Key exclusion criteria (2 listed)
- Any non- histologic confirmed diagnosis of FLC
- Participants with insufficient clinical/ follow up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Registry of Therapy of patient's diagnosed with FibroLamellarRegistry of Therapy of patient's diagnosed with FibroLamellar | Procedure or surgery | – |
Primary outcome
To describe the natural history and clinical outcomes of patients with Fibrolamellar carcinoma of the liver
Time frame: 2 years
The following data will be outcomes of interest in this study: treatments received including compliance and tolerability, survival (overall and progress free survival), clinicopathological outcomes. Survival outcomes, response rates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrolamellar Cancer of the Liver, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the natural history and clinical outcomes of patients with Fibrolamellar carcinoma of the liver (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.