Hepatocellular CarcinomaNCT04189809
Discrepancies in Management of Hepatocellualr Carcinoma Between Practice and Recommendations
An observational study of Hepatocellular Carcinoma, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2019to 25 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patient with diagnosis of HCC proven based on tumor sampling or imaging findings
Who may be able to join
- Any patient presented at a multidisciplinary meeting within the OncoOccitanie network during the years 2018 and 2019 for the management of hepatocellular carcinoma
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Hepatocellular Carcinoma : Discrepancies Between BCLC Classification and Clinical Practice in a Large Regional Multicentric Cohort
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.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, Chronic liver diseases, Interventional Radiology, Surgical, Therapy, resection
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of therapeutic proposals correctly predicted by the BCLC international classification
Rate of therapeutic proposals correctly predicted by the BCLC international classification
Measured: 1 day
Secondary outcomes (1)
Rates and causes of discrepancies
Rates and causes of discrepancies
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start30 Nov 2019
- Primary completion1 Mar 2020
- Study completion25 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BORIS GUIU, PU-PH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189809
- Sponsor's protocol ID
- RECHMPL19_0572
- Status last verified
- Mar 2020
- First submitted
- 4 Dec 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Hepatocellular Carcinoma : Discrepancies Between BCLC Classification and Clinical Practice in a Large Regional Multicentric Cohort
- ClinicalTrials.gov ID
- NCT04189809
- Acronym / sponsor ID
- RECHMPL19_0572
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, Chronic liver diseases, Interventional Radiology, Surgical, Therapy, resection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 25 Dec 2020 (estimated)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient with diagnosis of HCC proven based on tumor sampling or imaging findings
Key inclusion criteria (1 listed)
- Any patient presented at a multidisciplinary meeting within the OncoOccitanie network during the years 2018 and 2019 for the management of hepatocellular carcinoma
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of therapeutic proposals correctly predicted by the BCLC international classification
Time frame: 1 day
Rate of therapeutic proposals correctly predicted by the BCLC international classification
1 secondary outcome
Rates and causes of discrepancies
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BORIS GUIU, PU-PH study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of therapeutic proposals correctly predicted by the BCLC international classification (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.