NCT04189809

Brief Summary

The complex management of hepatocellular carcinoma has prompted many learned societies to issue their management recommendations or decision-making algorithms to best assist in the therapeutic decision-making of patients with HCC. Over time, the use of the BCLC algorithm (for Barcelona Clinic Liver Cancer) has become essential, at least in the West, thanks to a relatively simple and applicable classification system, and the clinical validation of numerous studies. The BCLC algorithm thus relies on the general condition of the patient, the CHILD-PUGH score reflecting hepatic function, and the tumor extension to propose one or more therapeutic solutions according to the level of scientific evidence, associating with each one. subgroups the expected survival. While this BCLC classification has the merit of having the protocol for the management of HCC, thus avoiding many drifts related to possible local preferences, it also has many defects. For example, this classification is only rarely updated, which limits the integration of innovative therapies. Then, its design and updates were supported by the recommendations of a limited group of experts that is not necessarily representative of all the key players present daily in the management of CHC. Finally, some studies have begun to point out that this classification was interesting from a theoretical point of view, but that in practice the diversity of complex situations meant that its care recommendations were not applicable in a significant number of cases. The objective of our study is to analyze the applicability of the BCLC classification in real-life situations. To overcome possible "center effects", the investigators analyzed in an exhaustive way the therapeutic decisions taken during the multi-disciplinary consultation meetings of 2018 and 2019 at the level of a large French region, by relying on the regional network of OncoOccitanie Oncology Record. In a second step, the investigators will analyze the causes of the discrepancies to finally propose an improvement of this BCLC classification.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 30, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

December 4, 2019

Last Update Submit

March 9, 2020

Conditions

Keywords

HCCChronic liver diseasesInterventional RadiologySurgicalTherapyresection

Outcome Measures

Primary Outcomes (1)

  • Rate of therapeutic proposals correctly predicted by the BCLC international classification

    Rate of therapeutic proposals correctly predicted by the BCLC international classification

    1 day

Secondary Outcomes (1)

  • Rates and causes of discrepancies

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patient with diagnosis of HCC proven based on tumor sampling or imaging findings

You may qualify if:

  • \- Any patient presented at a multidisciplinary meeting within the OncoOccitanie network during the years 2018 and 2019 for the management of hepatocellular carcinoma

You may not qualify if:

  • Histological type other than CHC
  • Multidisciplinary meeting that does not lead to a therapeutic decision (such as the continuation of further investigations, biopsy sampling, or active surveillance)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • BORIS GUIU, PU-PH

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 6, 2019

Study Start

November 30, 2019

Primary Completion

March 1, 2020

Study Completion

December 25, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations