Discrepancies in Management of Hepatocellualr Carcinoma Between Practice and Recommendations

Hepatocellular Carcinoma Clinical Trial

Official title:

Management of Hepatocellular Carcinoma : Discrepancies Between BCLC Classification and Clinical Practice in a Large Regional Multicentric Cohort

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04189809
• Other study ID #: RECHMPL19_0572
• Status: Active, not recruiting
• Start date: November 30, 2019
• Est. completion date: December 25, 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 25, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

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

Exclusion criteria:

• 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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rates and causes of discrepancies	Rates and causes of discrepancies	1 day