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NCT04874519 Clinical Trial

Registry to Collect Health Information Related to Fibrolamellar Cancer

Liver Cancer Clinical Trial

Official title:
Fibrolamellar Carcinoma Global Dynamic Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04874519
Other study ID # 20-543
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 24, 2021
Est. completion date April 30, 2025

Study information
Verified date March 2024
Source Memorial Sloan Kettering Cancer Center
Contact Ghassan Abou-Alfa, MD, MBA
Phone 646-888-4184
Email abou-alg@MSKCC.ORG
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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