NCT04874519

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

November 24, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

4 years

First QC Date

May 3, 2021

Last Update Submit

November 11, 2025

Conditions

Keywords

fibrolamellar cancerliver cancer20-543Memorial Sloan Kettering Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

QuestionnaireBEHAVIORAL

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.

Participants with Fibrolamellar Carcinoma/FLC

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Participants residing in the European Union (EU).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Fibrolamellar hepatocellular carcinomaLiver Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ghassan Abou-Alfa, MD, MBA

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 5, 2021

Study Start

November 24, 2021

Primary Completion

November 10, 2025

Study Completion

November 10, 2025

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Locations