Prospective Liver Study | NCT01539993

Studies
Prospective Liver Study

NCT01539993

Sponsor

Emory University

Status

Completed

Last Update Posted

May 28, 2014Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Liver Cancer

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

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Feb 15, 2012

First Submission Date that Met QC Criteria

Feb 27, 2012

First Posted Date

Feb 28, 2012Estimated

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

May 23, 2014

Last Update Posted Date

May 28, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyun Kevin Kim, MD FSIR, Director of Interventional Radiology and Image-Guided Medicine., Emory UniversityPrincipal Investigator

Lead Sponsor

Emory UniversityOTHER

Collaborators

Not provided

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 study is designed for patients diagnosed with Liver cancer to collect information about the relationship between types of liver cancer, methods of treatment and outcomes over time.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

400Actual

Label	Type	Description	Intervention Names
1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess efficacy of percutaneous and transarterial treatments for liver cancer.	QOL questionnaire will be collected during follow up visit.	1 month

Secondary Outcomes

Measure	Description	Time Frame
long term follow up	Patients will be administered QOL during 3 months, 6 months and 1 year follow up.	3 months, 6 months 1year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with Hepatocellular carcinoma and referred for percutaneous liver treatment.

Exclusion Criteria:

Severe liver disfunction
Active uncontrolled infection
Significant underlying medical of physical illness

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

Patients 18 yrs and older with a diagnosis of Hepatocellular carcinoma and elegible for percutaneous liver treatments

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin S Kim, MD	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University		Atlanta	Georgia	30322	United States

Condition Browse Module

MeSH Terms

ID	Term
D008113	Liver Neoplasms
D006528	Carcinoma, Hepatocellular
D018281	Cholangiocarcinoma

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