- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05730686
FibroLamellar Carcinoma: an International Registry Study (FLiCIR)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22HH8014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fibrolamellar Cancer of the Liver
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Memorial Sloan Kettering Cancer CenterJohns Hopkins University; Novartis Pharmaceuticals; University of California,... and other collaboratorsCompletedFibrolamellar Carcinoma | Fibrolamellar Liver CancerUnited States
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Sidney Kimmel Comprehensive Cancer Center at Johns...Bristol-Myers Squibb; Fibrolamellar Cancer FoundationRecruitingFibrolamellar Hepatocellular Carcinoma (FLC)United States
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Memorial Sloan Kettering Cancer CenterRecruitingLiver Cancer | Fibrolamellar Cancer | FLCUnited States
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Ethicon, Inc.Terminated
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Ethicon, Inc.RecruitingLiver Cancer | Cancer of the Liver | Neoplasms, LiverUnited Kingdom, United States, Netherlands, Singapore, France, Germany, China, Korea, Republic of
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Masonic Cancer Center, University of MinnesotaCompletedLiver Neoplasms | Liver Cancer | Hepatoma | Biliary Cancer | Cancer of the LiverUnited States
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Sidney Kimmel Comprehensive Cancer Center at Johns...Fibrolamellar Cancer FoundationWithdrawnHepatocellular Carcinoma | Fibrolamellar Hepatocellular Carcinoma | Hepatocellular Carcinoma (Fibrolamellar Variant)United States
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CASI Pharmaceuticals, Inc.CompletedAdvanced Adult Hepatocellular Carcinoma | Advanced Fibrolamellar CarcinomaUnited States
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Allison O'Neill, MDRecruitingLiver Cancer | Fibrolamellar Carcinoma | Hepatocellular Carcinoma, Childhood | Liver Cancer, PediatricUnited States
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Eisai Inc.Eisai LimitedCompletedLesions of the LiverJapan
Clinical Trials on Registry of Therapy of patient's diagnosed with FibroLamellar
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University Hospital, GenevaRecruitingAccidental HypothermiaAustria, Poland, Switzerland, Spain, Denmark, Germany, Italy, Japan, United Kingdom
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Deutsches Herzzentrum MuenchenUnknownAcute Coronary Syndrome | Tako-Tsubo Cardiomyopathy | Stress-induced CardiomyopathyGermany
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University of BolognaAzienda Ospedaliera Universitaria Policlinico Paolo GiacconeNot yet recruitingCancer Related Cardiovascular ToxicityItaly, North Macedonia, Serbia
-
University Medicine GreifswaldRecruitingRetinopathy of PrematurityGermany, Greece, Austria, Bulgaria, Estonia, France, Kosovo, Poland, Spain, Switzerland, Turkey, Ukraine
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Hospices Civils de LyonCompletedSurgery | PhalloplastyFrance
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Hanyang UniversityUnknownCardiac ArrestKorea, Republic of
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University of KentuckyRecruiting
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Postgraduate Institute of Dental Sciences RohtakCompletedPolycystic Ovary Syndrome | Gingival InflammationIndia
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Centre Hospitalier Universitaire de NīmesRecruiting
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Military Institute of Medicine, PolandWroclaw Medical University; Medical University of Gdansk; 4th Military Hospital; Military University of TechnologyCompleted