Registry to Collect Health Information Related to Fibrolamellar Cancer

Fibrolamellar Carcinoma Global Dynamic Registry

The purpose of this study is to collect information about people with fibrolamellar cancer (FLC). This study is a registry of people with FLC around the world. This study will involve collecting information about participants, their medical history and the regular medical care they receive for FLC. The study will not provide treatment for your cancer.

Study Overview

• Status: Completed
• Conditions: Liver Cancer; Fibrolamellar Cancer; FLC
• Intervention / Treatment: Behavioral: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects may also be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC). If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.

Description

Inclusion Criteria:

• Age 13 years or older.
• Personal history of histologically proven fibrolamellar carcinoma (clinical or radiographical suspicion of FLC must be confirmed at MSK or an external hospital)

• Participants must have access to electronic devices that meet the following minimum requirements:

  • Ability to connect to the internet
  • Capability of running modern internet browers (such as Google Chrome, Internet Explorer, Safari, or Mozilla Firefox).
• Participants must have a google account

Exclusion Criteria:

• Participants residing in the European Union (EU).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants with Fibrolamellar Carcinoma/FLC; Participants will have a personal history of histologically proven fibrolamellar carcinoma (clinical or radiographical suspicion of FLC must be confirmed at MSK or an external hospital)

Behavioral: Questionnaire; The questionnaire will be completed at the time of enrollment, every month, and at the end of study. Regardless of current interventions or lack of, assessments will be completed at enrollment and then monthly for a total of 18 months. In order to provide reasonable flexibility to participants, physicians, and study teams, the assessments can be completed within 30 days of the last assessment. The next month will be recalculated based on last reporting date.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Build a Fibrolamellar Cancer/FLC registry	To build a registry of Fibrolamellar Cancer/FLC through patient reported information, that could be studied further in future studies.	18 months

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Ghassan Abou-Alfa, MD, MBA, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Actual): November 10, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: liver cancer; fibrolamellar cancer; 20-543; Memorial Sloan Kettering Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms; Fibrolamellar hepatocellular carcinoma; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 20-543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No