Hepatocellular CarcinomaNCT03081637
FLNA in HCC Patients
An observational study of Hepatocellular Carcinoma, run by University of Milan.
Trial summary
The risk of recurrence after hepatectomy for hepatocellular carcinoma (HCC) is very high. Having a predictive marker of early recurrence (ER) would be desirable to personalize the follow-up and possibly develop new targeted therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 2 Mar 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: HCC patients submitted to hepatectomy at our unit in the above mentioned frame time.
Who may be able to join
- The inclusion criteria were represented by the histological positivity for HCC with complete clinical, surgical, pathological, and follow-up data.
Who cannot join
- Patients preoperatively treated with chemotherapy or trans-arterial therapy were excluded.
- Similarly, patients operated for recurrent HCC or with non-radical surgery or with missing data were excluded.
About this study
Official title: Filamin A Expression in HCC Patients
The risk of recurrence after hepatectomy for hepatocellular carcinoma (HCC) is very high. Having a predictive marker of early recurrence (ER) would be desirable to personalize the follow-up and possibly develop new targeted therapy. The aim of this study was to test the expression of Filamin A (FLNA) in a cohort of patients operated for HCC.
Read the detailed description
A consecutive cohort of resected HCC patients will be analyzed. Several different prognostic factors, including FLNA expression, will be tested against the risk of ER. FLNA expression will be analyzed with immunohistochemistry in the intra-tumoral and extra-tumoral tissue compartments using a dedicated tissue microarray.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of expression of Filamin A (FLNA) in HCC specimens from patients resected for HCC.
The rate of expression of FLNA in HCC specimens will be measured using standard immunohistochemistry methodology on surgical specimens. Such expression rate will be correlated to several different clinical and pathological parameters.
Measured: 2 years after surgery as a minimum follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start1 Jan 2004
- Primary completion31 Dec 2014
- Study completion2 Mar 2017
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.
- 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
- 115 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
- NCT03081637
- Sponsor's protocol ID
- FLNA in HCC
- Status last verified
- May 2017
- First submitted
- 2 Mar 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Filamin A Expression in HCC Patients
- ClinicalTrials.gov ID
- NCT03081637
- Acronym / sponsor ID
- FLNA in HCC
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 16 Mar 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.
The risk of recurrence after hepatectomy for hepatocellular carcinoma (HCC) is very high. Having a predictive marker of early recurrence (ER) would be desirable to personalize the follow-up and possibly develop new targeted therapy. The aim of this study was to test the expression of Filamin A (FLNA) in a cohort of patients operated for HCC.
Detailed description
A consecutive cohort of resected HCC patients will be analyzed. Several different prognostic factors, including FLNA expression, will be tested against the risk of ER. FLNA expression will be analyzed with immunohistochemistry in the intra-tumoral and extra-tumoral tissue compartments using a dedicated tissue microarray.
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
- HCC patients submitted to hepatectomy at our unit in the above mentioned frame time.
Key inclusion criteria (1 listed)
- The inclusion criteria were represented by the histological positivity for HCC with complete clinical, surgical, pathological, and follow-up data.
Key exclusion criteria (2 listed)
- Patients preoperatively treated with chemotherapy or trans-arterial therapy were excluded.
- Similarly, patients operated for recurrent HCC or with non-radical surgery or with missing data were excluded.
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 expression of Filamin A (FLNA) in HCC specimens from patients resected for HCC.
Time frame: 2 years after surgery as a minimum follow-up
The rate of expression of FLNA in HCC specimens will be measured using standard immunohistochemistry methodology on surgical specimens. Such expression rate will be correlated to several different clinical and pathological parameters.
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 1 Jun 2017.
Related trials for Hepatocellular Carcinoma
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Not yet recruitingPhase 2
Study Evaluating the Efficacy and Safety of BGB-B2033 in Participants With Advanced Hepatocellular Carcinoma
Hepatocellular Cancer, Liver Cancer
Active, not recruitingPhase 1/2
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer
Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8
Not yet recruitingObservational study
Integration of Imaging, Molecular, Pathological, and Clinical Outcome Data in Hepatocellular Carcinoma.
Resectable Hepatocellular Carcinoma (HCC)
Active, not recruitingPhase 3
Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
Recurrent Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7
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 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 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: finished, as of the sponsor's last update on 1 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?
Rate of expression of Filamin A (FLNA) in HCC specimens from patients resected for HCC. (time frame: 2 years after surgery as a minimum follow-up). 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 1 Jun 2017.