HCCNCT03875417
Multidisciplinary Management of HCC in Elderly Patients
An observational study of HCC and Quality of Life, run by Azienda Policlinico Umberto I at 1 site in Italy.
Trial summary
Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- HCC, Quality of Life
- What is being tested?
- liver resection, Thermic ablation and Transcatheter arterial chemoembolization
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 31 Oct 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: all patients submitted to surgery for HCC nodules resection between 2002 and 2017
Who may be able to join
- HCC patient
- eligible for surgery
Who cannot join
- non eligible for surgery at first HCC diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidisciplinary HCC Treatment in Elderly : QoL and Survival Analysis
Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.
Read the detailed description
Introduction- Hepatocellular carcinoma (HCC) is the most common primary liver malignancy. It usually develops in cirrhotic liver with high recurrence rates. More than 2/3 of patients are elderly, often excluded from surgery and follow-up protocols. Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.
Materials and methods- 126 patients, aged between 65 and 90 years, submitted to liver resection for HCC were enrolled. They were divided into three classes. Class 1 included patients submitted to major resections, Class 2 to minor resections and Class 3 to minor resections associated with thermoablation. All of them were clinically and radiologically followed up. Patients who developed recurrences (Group A) were referred to further treatments (surgery, interventional radiology or pharmacological therapy). Mortality, disease-free survival (DFS), overall survival (OS) and quality of life (QoL) were evaluated and compared with non-recurrent patients (Group B).
Used interventional radiology means were Radiofrequency ablation (RF), microwaves ablation (MWA) or transcatheter arterial chemoembolization (TACE).
- Conditions
- HCC, Quality of Life
- Being tested
- liver resection, Thermic ablation, Transcatheter arterial chemoembolization
- Keywords
- HCC, HCC in elderly, recurrent HCC, Liver resection, Quality of Life, intervention radiology, RF, TACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver resectionProcedure or surgery
resection of one or more HCC nodules within the liver
Thermic ablationProcedure or surgery
Also called RF (radiofrequency ablation) / MWA (microwaves ablation)
ablation of HCC nodule through a percutaneous needle, by using radiofrequency or microwaves
Transcatheter arterial chemoembolizationProcedure or surgery
embolization of HCC nodule via drug-eluted microbeads.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients who developed HCC recurrences after surgery and treated with re-resection, or microinvasive non-surgical means. Receives: Procedure: liver resection; Procedure: Thermic ablation; Procedure: Transcatheter arterial chemoembolization | |
| Group B | Patients who did not develop recurrences after surgery. Receives: Procedure: liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
survival in months
Measured: follow up time 1-16 years
Disease free survival
survival without recurrences in months
Measured: follow up time 1-16 years
Secondary outcomes (6)
Karnofsky performance scale
evaluation of performance status in dimensionless scale 0 - 100
Measured: follow up time 1-16 years
Activity of Daily living
assess the ability to manage common routine activities evaluated in dimensionless scale 1-6
Measured: follow up time 1-16 years
Instrumental Activity of Daily living
assess the ability to use common instruments evaluated in dimensionless scale 1-8
Measured: follow up time 1-16 years
Blood Haemoglobin
evaluation of mean haemoglobin levels in g/dl
Measured: follow up time 1-16 years
serum Albumin
evaluation of mean albumin levels in g/dl
Measured: follow up time 1-16 years
Geriatric Depression Scale
evaluation of depression in patients in dimensionless scale 0 - 15
Measured: follow up time 1-16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Jan 2018
- Primary completion30 May 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Stefania Brozzetti, Azienda Policlinico Umberto I
- Investigators
- Stefania Brozzetti, Professor, Principal investigator, Policlinico Umberto I - Sapienza università di Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875417
- Sponsor's protocol ID
- HEP001
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2019
- Last updated
- 14 Mar 2019
- 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 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary HCC Treatment in Elderly : QoL and Survival Analysis
- ClinicalTrials.gov ID
- NCT03875417
- Acronym / sponsor ID
- HEP001
- Conditions
- HCC, Quality of Life
- Keywords
- HCC, HCC in elderly, recurrent HCC, Liver resection, Quality of Life, intervention radiology, RF, TACE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 14 Mar 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.
Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.
Detailed description
Introduction- Hepatocellular carcinoma (HCC) is the most common primary liver malignancy. It usually develops in cirrhotic liver with high recurrence rates. More than 2/3 of patients are elderly, often excluded from surgery and follow-up protocols. Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.
Materials and methods- 126 patients, aged between 65 and 90 years, submitted to liver resection for HCC were enrolled. They were divided into three classes. Class 1 included patients submitted to major resections, Class 2 to minor resections and Class 3 to minor resections associated with thermoablation. All of them were clinically and radiologically followed up. Patients who developed recurrences (Group A) were referred to further treatments (surgery, interventional radiology or pharmacological therapy). Mortality, disease-free survival (DFS), overall survival (OS) and quality of life (QoL) were evaluated and compared with non-recurrent patients (Group B).
Used interventional radiology means were Radiofrequency ablation (RF), microwaves ablation (MWA) or transcatheter arterial chemoembolization (TACE).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: liver resection, Procedure: Thermic ablation, Procedure: Transcatheter arterial chemoembolizationPatients who developed HCC recurrences after surgery and treated with re-resection, or microinvasive non-surgical means. |
| Group B | – | Procedure: liver resectionPatients who did not develop recurrences after surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- all patients submitted to surgery for HCC nodules resection between 2002 and 2017
Key inclusion criteria (2 listed)
- HCC patient
- eligible for surgery
Key exclusion criteria (1 listed)
- non eligible for surgery at first HCC diagnosis
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 |
|---|---|---|
| liver resectionresection of one or more HCC nodules within the liver | Procedure or surgery | Group A, Group B |
| Thermic ablationAlso: RF (radiofrequency ablation) / MWA (microwaves ablation)ablation of HCC nodule through a percutaneous needle, by using radiofrequency or microwaves | Procedure or surgery | Group A |
| Transcatheter arterial chemoembolizationembolization of HCC nodule via drug-eluted microbeads. | Procedure or surgery | Group A |
Primary outcome
Overall survival
Time frame: follow up time 1-16 years
survival in months
Disease free survival
Time frame: follow up time 1-16 years
survival without recurrences in months
6 secondary outcomes
Karnofsky performance scale
Time frame: follow up time 1-16 years
Activity of Daily living
Time frame: follow up time 1-16 years
Instrumental Activity of Daily living
Time frame: follow up time 1-16 years
Blood Haemoglobin
Time frame: follow up time 1-16 years
serum Albumin
Time frame: follow up time 1-16 years
Geriatric Depression Scale
Time frame: follow up time 1-16 years
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 14 Mar 2019.
- 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.
Stefania Brozzetti, Professor principal investigator
Policlinico Umberto I - Sapienza università di Roma
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 HCC and Quality of Life, run by Azienda Policlinico Umberto I at 1 site in Italy.
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 1 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 14 Mar 2019. 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 Italy. 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?
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?
Overall survival (time frame: follow up time 1-16 years). The study lists 2 primary outcomes in all. 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 14 Mar 2019.