Liver CarcinomaNCT03178409
Combined HCC-MFCCC
An observational study of Liver Carcinoma and Hepatocellular Carcinoma, run by University of Milan.
Trial summary
Combined hepatocellular and mass-forming cholangiocarcinoma (cHCC-MFCCC) is a rare tumor. The aim of this study was the analysis of the outcome comparing such tumor with classic hepatocellular carcinoma (HCC) and mass-forming cholangiocarcinoma (MFCCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Carcinoma, Hepatocellular Carcinoma, Cholangiocarcinoma
- What is being tested?
- Hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 15 May 2017
- 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: Patients affected by cHCC-MFCCC, or HCC or MFCCC.
Who may be able to join
- positive histology for cHCC-MFCCC, HCC, and MFCCC
- complete clinical, surgical, pathological and follow-up data.
Who cannot join
- patients preoperatively treated with chemotherapy, radiofrequency ablation or trans-arterial therapies were excluded.
- patients operated for recurrent disease and/or with non-radical surgery
- patients with missing data were also excluded
About this study
Official title: Survival After Hepatectomy for Combined Hepatocellular Cholagiocarcinoma
Combined hepatocellular and mass-forming cholangiocarcinoma (cHCC-MFCCC) is a rare tumor. The aim of this study was the analysis of the outcome comparing such tumor with classic hepatocellular carcinoma (HCC) and mass-forming cholangiocarcinoma (MFCCC).
Read the detailed description
The institutional prospectively maintained database was queried, and 20 patients with cHCC-MFCCC were identified. A 2:1 match was performed with 40 patients operated in the same period for HCC, and with 40 operated for MFCCC. Only T1 or T2 patients N0 M0 were considered. Primary endpoint was the overall survival (OS) and disease-free survival (DFS).
- Conditions
- Liver Carcinoma, Hepatocellular Carcinoma, Cholangiocarcinoma, Surgery
- Being tested
- Hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepatectomyProcedure or surgery
Also called Liver resection, Liver surgery
Removal of a part of the liver
| Study group | Role | What they receive |
|---|---|---|
| cHCC-MFCCC | Patients affected by combined HCC-MFCCC Receives: Procedure: Hepatectomy | |
| HCC | Patients affected by classical HCC Receives: Procedure: Hepatectomy | |
| MFCCC | Patients affected by classical MFCCC Receives: Procedure: Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival analysis
Analysis of overall and disease-free survival of patients resected for cHCC-MFCCC versus those resected for HCC versus those resected for MFCCC
Measured: From 3 months after surgery up to 60 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Jan 2004
- Primary completion31 Dec 2014
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CarcinomaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Guido Torzilli, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178409
- Sponsor's protocol ID
- cHCC-MFCCC
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival After Hepatectomy for Combined Hepatocellular Cholagiocarcinoma
- ClinicalTrials.gov ID
- NCT03178409
- Acronym / sponsor ID
- cHCC-MFCCC
- Conditions
- Liver Carcinoma, Hepatocellular Carcinoma, Cholangiocarcinoma, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 6 Jun 2017 (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.
Combined hepatocellular and mass-forming cholangiocarcinoma (cHCC-MFCCC) is a rare tumor. The aim of this study was the analysis of the outcome comparing such tumor with classic hepatocellular carcinoma (HCC) and mass-forming cholangiocarcinoma (MFCCC).
Detailed description
The institutional prospectively maintained database was queried, and 20 patients with cHCC-MFCCC were identified. A 2:1 match was performed with 40 patients operated in the same period for HCC, and with 40 operated for MFCCC. Only T1 or T2 patients N0 M0 were considered. Primary endpoint was the overall survival (OS) and disease-free survival (DFS).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cHCC-MFCCC | – | Procedure: HepatectomyPatients affected by combined HCC-MFCCC |
| HCC | – | Procedure: HepatectomyPatients affected by classical HCC |
| MFCCC | – | Procedure: HepatectomyPatients affected by classical MFCCC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by cHCC-MFCCC, or HCC or MFCCC.
Key inclusion criteria (2 listed)
- positive histology for cHCC-MFCCC, HCC, and MFCCC
- complete clinical, surgical, pathological and follow-up data.
Key exclusion criteria (3 listed)
- patients preoperatively treated with chemotherapy, radiofrequency ablation or trans-arterial therapies were excluded.
- patients operated for recurrent disease and/or with non-radical surgery
- patients with missing data were also excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepatectomyAlso: Liver resection, Liver surgeryRemoval of a part of the liver | Procedure or surgery | HCC, MFCCC, cHCC-MFCCC |
Primary outcome
Survival analysis
Time frame: From 3 months after surgery up to 60 months after surgery
Analysis of overall and disease-free survival of patients resected for cHCC-MFCCC versus those resected for HCC versus those resected for MFCCC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Carcinoma and Hepatocellular Carcinoma, run by University of Milan.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival analysis (time frame: From 3 months after surgery up to 60 months after surgery). 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 6 Jun 2017.