Hepatocellular Research Registry | NCT00178893

Studies
Hepatocellular Research Registry

NCT00178893

Sponsor

Vanderbilt University

Status

Unknown status

Last Update Posted

Apr 18, 2019Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Hepatocytes

Interventions

Not provided

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

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 2005Estimated

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

Apr 16, 2019

Last Update Posted Date

Apr 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is a registry of human hepatocytes (liver cells) for research purposes.

Detailed Description

Patients scheduled for partial hepatectomy/liver surgery are asked permission to use their discarded liver tissue for purposes of studying:

how drugs/medicines affect the liver and
the effects of storing liver cells in the cold or freezing.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persons undergoing partial hepatectomy/liver surgery for any reason.

Exclusion Criteria:

Persons with known HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
A diagnosis of hepatocellular carcinoma without negative serologies
A diagnosis of cholangiocarcinoma, where the total bilirubin has ever been greater or equal to 3.0
The presence of a biliary drainage tube
Active sepsis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any patient having liver resection operation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carla M Ramsey, RN, BSN	Contact	615-936-0834		carla.thomas@Vanderbilt.edu
Claudia Medlin	Contact	615-936-2573		claudia.medlin@vanderbilt.edu

Overall Officials

Name	Affiliation	Role
Sunil K Geevarghese, MD, MSCI	Vanderbilt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University	Recruiting	Nashville	Tennessee	37232-4753	United States