Liver CancerNCT02102971
Observational Study of Biomarker During Liver Surgery
An observational study of Liver Cancer and Hepatobiliary Tract Adenomas and Carcinomas, run by University of Florida at 1 site in United States.
Trial summary
The investigators would like to study whether Sirtuin 1 (SIRT1) plays a cytoprotective role in liver ischemia/reperfusion, and ultimately to develop therapeutic strategies to improve hepatic function of patients with liver diseases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cancer, Hepatobiliary Tract Adenomas and Carcinomas
- What is being tested?
- Hepatocellular carcinoma
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 6 Jun 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver Disease Requring Liver Resection Surgery
Who may be able to join
- liver resection > 2 segments,
- plate count > 100 x 109/L, and
- prothrombin activity >60%.
Who cannot join
- liver cirrhosis,
- portal hypertension,
- steatohepatitis or severe steatosis,
- patients receiving additional ablation therapies,
- laparoscopic resection, and
- simultaneous extrahepatic procedures such as colorectal resection or pancreatoduodenectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autophagy in Liver Injury: Changes in Autophagy Biomarkers During Liver Surgery
The investigators would like to study whether Sirtuin 1 (SIRT1) plays a cytoprotective role in liver ischemia/reperfusion, and ultimately to develop therapeutic strategies to improve hepatic function of patients with liver diseases.
Read the detailed description
If asked to participate in this research study, it is because a liver resection/liver transplantation surgery has been scheduled. During the procedure a small section will be collected for additional testing of Sirtuin 1. In addition, information concerning the liver disease, laboratory and pathology results after surgery will be collected by the investigators.
- Being tested
- Hepatocellular carcinoma
- Keywords
- liver, ischemia, reperfusion
- Medical subject headings
- Liver Neoplasms, Carcinoma, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatocellular carcinomaProcedure or surgery
Also called Liver resection, Liver transplantation surgery
Participants undergoing a liver resection/liver transplantation surgery. During the liver surgery a small piece of tissue will be removed to undergo additional laboratory testing.
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular carcinoma | Participants undergoing a liver resection/liver transplantation surgery. During the liver surgery a small piece of tissue will be removed to undergo additional laboratory testing. Receives: Procedure: Hepatocellular carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical analysis of sirtuin1 from liver tissues during liver surgery
Measured: 30 minutes during liver surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startOct 2014
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Why it stopped: Expired with UF IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae-Sung Kim, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102971
- Sponsor's protocol ID
- IRB201400182 -N
- Other IDs
- R01DK079879
- Status last verified
- Sep 2019
- First submitted
- 31 Mar 2014
- Last updated
- 25 Sep 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 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autophagy in Liver Injury: Changes in Autophagy Biomarkers During Liver Surgery
- ClinicalTrials.gov ID
- NCT02102971
- Acronym / sponsor ID
- IRB201400182 -N
- Keywords
- liver, ischemia, reperfusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Expired with UF IRB.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2014
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 3 Apr 2014 (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.
The investigators would like to study whether Sirtuin 1 (SIRT1) plays a cytoprotective role in liver ischemia/reperfusion, and ultimately to develop therapeutic strategies to improve hepatic function of patients with liver diseases.
Detailed description
If asked to participate in this research study, it is because a liver resection/liver transplantation surgery has been scheduled. During the procedure a small section will be collected for additional testing of Sirtuin 1. In addition, information concerning the liver disease, laboratory and pathology results after surgery will be collected by the investigators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular carcinoma | – | Procedure: Hepatocellular carcinomaParticipants undergoing a liver resection/liver transplantation surgery. During the liver surgery a small piece of tissue will be removed to undergo additional laboratory testing. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver Disease Requring Liver Resection Surgery
Key inclusion criteria (3 listed)
- liver resection > 2 segments,
- plate count > 100 x 109/L, and
- prothrombin activity >60%.
Key exclusion criteria (6 listed)
- liver cirrhosis,
- portal hypertension,
- steatohepatitis or severe steatosis,
- patients receiving additional ablation therapies,
- laparoscopic resection, and
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 |
|---|---|---|
| Hepatocellular carcinomaAlso: Liver resection, Liver transplantation surgeryParticipants undergoing a liver resection/liver transplantation surgery. During the liver surgery a small piece of tissue will be removed to undergo additional laboratory testing. | Procedure or surgery | Hepatocellular carcinoma |
Primary outcome
Biochemical analysis of sirtuin1 from liver tissues during liver surgery
Time frame: 30 minutes during liver surgery
Results and safety
The study was stopped early (reason given: Expired with UF IRB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 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.
Jae-Sung Kim, PhD principal investigator
University of Florida
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 Liver Cancer and Hepatobiliary Tract Adenomas and Carcinomas, run by University of Florida at 1 site in United States.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 25 Sep 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 United States. 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 was stopped early (reason given: Expired with UF IRB.). Results are not available in the source record.
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?
Biochemical analysis of sirtuin1 from liver tissues during liver surgery (time frame: 30 minutes during liver 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 25 Sep 2019.