CirrhosisUniRerNCT01657695
Hepatocellular Carcinoma Growth and Molecular Aggressiveness
An observational study of Cirrhosis and Hepatocellular Carcinoma, run by Prof. Facchinetti Fabio at 1 site in Italy.
Trial summary
Our long-term objective is to develop a new tool based on a (molecular-biology) integrated imaging technology able to characterize and categorize hepatocellular carcinoma (HCC) patients in need of liver transplant (LT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Hepatocellular Carcinoma
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2008to Aug 2012
- 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: Cirrhotic patients, at first diagnosis of HCC and potential liver transplant candidates
Who may be able to join
- Cirrhotic patients at first US identification of a focal lesion compatible with HCC
- Age > than 18 years
- No contraindications to performance of CT
- No contraindications to performance of US-guided liver biopsy
Who cannot join
- Patients will be excluded if
- are unable to give informed consent to the study;
- liver tissue obtained at biopsy is insufficient to perform molecular/histochemical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Integrated Molecular/Imaging Technology for Characterization of Biological Aggressiveness of HCC in Patients Candidate to Liver Transplant"
Our long-term objective is to develop a new tool based on a (molecular-biology) integrated imaging technology able to characterize and categorize hepatocellular carcinoma (HCC) patients in need of liver transplant (LT). To this end, our study aims at correlating specific imaging traits and fractional growth of individual tumors collected over a restricted time frame (T0 and at week 7 after first tumor detection), with a "molecular signature", obtained by custom microarray, histochemical and cytokine analysis. This should allow us to translate a series of purely morphologic information into a meaningful pathobiologic data sets. Validation of the integrated molecular-imaging tool will be performed prospectively by correlating the imaging-molecular data with HCC outcome in term of survival and disease-free survival after down staging procedures.
Read the detailed description
Organ allocation in our region is regulated according to MELD score. Patients with hepatocellular carcinoma (HCC) receive an additional score depending on size of the tumor and the time spent in transplant waiting list. However, the advantage given to these patients is uniform and does not take into account the profound biological heterogeneity of individual HCCs. To make the additional score righteous, the investigators need to identify patients with aggressively growing HCC who require salvage transplantation while those with slow-growing HCC do not deserve the additional score.
All cirrhotics with suspect HCC identified at routine US screening will be therefore enrolled in the prospective imaging and bio-molecular study.
They will be subjected to two computed tomography (CT) exams at 7 weeks interval to define fractional tumor growth and imaging traits, baseline US-guided liver biopsy for microarray and histochemical characterization, serum sampling for cytokine assay. Survival, disease-free survival after downstaging and transplant outcome will be recorded and analyzed in relation with imaging and molecular data. The investigators expect to set up an accurate imaging and molecular diagnostic tool able to identify patients with aggressive HCC requiring urgent access to transplant, reliable in predicting survival, standardisable and not too expensive.
- Conditions
- Cirrhosis, Hepatocellular Carcinoma
- Keywords
- HCC, Computed tomography, Gene expression, Fractional growth
- Medical subject headings
- Fibrosis, Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival will be compared between patients with rapidly and slowly growing HCCs
Measured: 2 years
Secondary outcomes (1)
Response to therapy
Response to therapy (liver transplant, resection, TACE) will be compared between rapidly and slowly growing HCCs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJun 2008
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies 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
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Facchinetti Fabio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
- Investigators
- Erica Villa, MD, Principal investigator, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657695
- Sponsor's protocol ID
- 10/08_CE_UniRer
- Acronym
- UniRer
- Status last verified
- Sep 2012
- First submitted
- 29 Jul 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Critelli RM, Milosa F, Romanzi A, Lasagni S, Marcelli G, Di Marco L, Pivetti A, Schepis F, Romagnoli D, Mancarella S, Dituri F, Martinez-Chantar ML, Giannelli G, Villa E. Upregulation of the oestrogen target gene SIX1 is associated with higher growth speed and decreased survival in HCV-positive women with hepatocellular carcinoma. Oncol Lett. 2022 Sep 21;24(5):395. doi: 10.3892/ol.2022.13515. eCollection 2022 Nov.
PubMed 36276500Villa E, Critelli R, Lei B, Marzocchi G, Camma C, Giannelli G, Pontisso P, Cabibbo G, Enea M, Colopi S, Caporali C, Pollicino T, Milosa F, Karampatou A, Todesca P, Bertolini E, Maccio L, Martinez-Chantar ML, Turola E, Del Buono M, De Maria N, Ballestri S, Schepis F, Loria P, Enrico Gerunda G, Losi L, Cillo U. Neoangiogenesis-related genes are hallmarks of fast-growing hepatocellular carcinomas and worst survival. Results from a prospective study. Gut. 2016 May;65(5):861-9. doi: 10.1136/gutjnl-2014-308483. Epub 2015 Feb 9.
PubMed 25666192
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Integrated Molecular/Imaging Technology for Characterization of Biological Aggressiveness of HCC in Patients Candidate to Liver Transplant"
- ClinicalTrials.gov ID
- NCT01657695
- Acronym / sponsor ID
- UniRer / 10/08_CE_UniRer
- Conditions
- Cirrhosis, Hepatocellular Carcinoma
- Keywords
- HCC, Computed tomography, Gene expression, Fractional growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Prof. Facchinetti FabioUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Aug 2012 (estimated)
- 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.
Our long-term objective is to develop a new tool based on a (molecular-biology) integrated imaging technology able to characterize and categorize hepatocellular carcinoma (HCC) patients in need of liver transplant (LT). To this end, our study aims at correlating specific imaging traits and fractional growth of individual tumors collected over a restricted time frame (T0 and at week 7 after first tumor detection), with a "molecular signature", obtained by custom microarray, histochemical and cytokine analysis. This should allow us to translate a series of purely morphologic information into a meaningful pathobiologic data sets. Validation of the integrated molecular-imaging tool will be performed prospectively by correlating the imaging-molecular data with HCC outcome in term of survival and disease-free survival after down staging procedures.
Detailed description
Organ allocation in our region is regulated according to MELD score. Patients with hepatocellular carcinoma (HCC) receive an additional score depending on size of the tumor and the time spent in transplant waiting list. However, the advantage given to these patients is uniform and does not take into account the profound biological heterogeneity of individual HCCs. To make the additional score righteous, the investigators need to identify patients with aggressively growing HCC who require salvage transplantation while those with slow-growing HCC do not deserve the additional score.
All cirrhotics with suspect HCC identified at routine US screening will be therefore enrolled in the prospective imaging and bio-molecular study.
They will be subjected to two computed tomography (CT) exams at 7 weeks interval to define fractional tumor growth and imaging traits, baseline US-guided liver biopsy for microarray and histochemical characterization, serum sampling for cytokine assay. Survival, disease-free survival after downstaging and transplant outcome will be recorded and analyzed in relation with imaging and molecular data. The investigators expect to set up an accurate imaging and molecular diagnostic tool able to identify patients with aggressive HCC requiring urgent access to transplant, reliable in predicting survival, standardisable and not too expensive.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic patients, at first diagnosis of HCC and potential liver transplant candidates
Key inclusion criteria (4 listed)
- Cirrhotic patients at first US identification of a focal lesion compatible with HCC
- Age > than 18 years
- No contraindications to performance of CT
- No contraindications to performance of US-guided liver biopsy
Key exclusion criteria (3 listed)
- Patients will be excluded if
- are unable to give informed consent to the study;
- liver tissue obtained at biopsy is insufficient to perform molecular/histochemical study
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
Survival
Time frame: 2 years
Survival will be compared between patients with rapidly and slowly growing HCCs
1 secondary outcome
Response to therapy
Time frame: 2 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 2 Oct 2012.
- Derived from this study: PubMed 36276500Critelli RM, Milosa F, Romanzi A, Lasagni S, Marcelli G, Di Marco L, Pivetti A, Schepis F, Romagnoli D, Mancarella S, Dituri F, Martinez-Chantar ML, Giannelli G, Villa E. Upregulation of the oestrogen target gene SIX1 is associated with higher growth speed and decreased survival in HCV-positive women with hepatocellular carcinoma. Oncol Lett. 2022 Sep 21;24(5):395. doi: 10.3892/ol.2022.13515. eCollection 2022 Nov.
- Derived from this study: PubMed 25666192Villa E, Critelli R, Lei B, Marzocchi G, Camma C, Giannelli G, Pontisso P, Cabibbo G, Enea M, Colopi S, Caporali C, Pollicino T, Milosa F, Karampatou A, Todesca P, Bertolini E, Maccio L, Martinez-Chantar ML, Turola E, Del Buono M, De Maria N, Ballestri S, Schepis F, Loria P, Enrico Gerunda G, Losi L, Cillo U. Neoangiogenesis-related genes are hallmarks of fast-growing hepatocellular carcinomas and worst survival. Results from a prospective study. Gut. 2016 May;65(5):861-9. doi: 10.1136/gutjnl-2014-308483. Epub 2015 Feb 9.
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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.
Erica Villa, MD principal investigator
University of Modena and Reggio Emilia
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 Cirrhosis and Hepatocellular Carcinoma, run by Prof. Facchinetti Fabio 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 4 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 2 Oct 2012. 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?
Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01657695, which also lists 2 linked publications.
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 2 Oct 2012.