- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03081637
FLNA in HCC Patients
May 31, 2017 updated by: Prof. Guido Torzilli, University of Milan
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
115
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
HCC patients submitted to hepatectomy at our unit in the above mentioned frame time.
Description
Inclusion Criteria:
- The inclusion criteria were represented by the histological positivity for HCC with complete clinical, surgical, pathological, and follow-up data.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years after surgery as a minimum follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2004
Primary Completion (Actual)
December 31, 2014
Study Completion (Actual)
March 2, 2017
Study Registration Dates
First Submitted
March 2, 2017
First Submitted That Met QC Criteria
March 15, 2017
First Posted (Actual)
March 16, 2017
Study Record Updates
Last Update Posted (Actual)
June 1, 2017
Last Update Submitted That Met QC Criteria
May 31, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLNA in HCC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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