Observational Study of Biomarker During Liver Surgery | NCT02102971

Studies
Observational Study of Biomarker During Liver Surgery

NCT02102971

Sponsor

University of Florida

Status

Terminated

Last Update Posted

Sep 25, 2019Actual

Enrollment

41Actual

Phase

Not provided

Conditions

Liver Cancer
Hepatobiliary Tract Adenomas and Carcinomas

Interventions

Hepatocellular carcinoma

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK079879	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Expired with UF IRB.

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jun 6, 2019Actual

Completion Date

Jun 6, 2019Actual

First Submitted Date

Mar 31, 2014

First Submission Date that Met QC Criteria

Apr 2, 2014

First Posted Date

Apr 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2019

Last Update Posted Date

Sep 25, 2019Actual

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Procedure: Hepatocellular carcinoma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hepatocellular carcinoma	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biochemical analysis of sirtuin1 from liver tissues during liver surgery		30 minutes during liver surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

liver resection > 2 segments,
plate count > 100 x 109/L, and
prothrombin activity >60%.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Liver Disease Requring Liver Resection Surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jae-Sung Kim, PhD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UF Health		Gainesville	Florida	32610	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008113	Liver Neoplasms
D002277	Carcinoma
D007511	Ischemia

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006498	Hepatectomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided