Genetic Profiling of Liver Cancer in Patients Undergoing... | NCT02412579

Studies
Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation

NCT02412579

Sponsor

Baylor Research Institute

Status

Completed

Last Update Posted

Jul 20, 2022Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

None - Standard of Care

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

Jul 2022

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

Mar 2015Actual

Primary Completion Date

Mar 17, 2022Actual

Completion Date

Mar 17, 2022Actual

First Submitted Date

Apr 6, 2015

First Submission Date that Met QC Criteria

Apr 6, 2015

First Posted Date

Apr 9, 2015Estimated

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

Jul 19, 2022

Last Update Posted Date

Jul 20, 2022Actual

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

The purpose of this study is to determine whether genetic markers unique to liver cancer are present and to assess usefulness as a diagnostic tool.

Detailed Description

Hepatocellular carcinoma (HCC) is the most common form of liver cancer and a growing trend worldwide. Decision-making regarding treatment for patients is limited by the lack of clinically actionable biomarkers. This is pronounced in the case for determining and monitoring liver transplant recipients. In an effort to improve diagnosis, the use of circulating serum-based microRNA isoforms (isomiRs) can serve as non-invasive, screening biomarkers in HCC patients pre- and post-transplantation of the liver.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hepatocellular Carcinoma with Cirrhosis		Subjects with hepatocellular carcinoma and cirrhosis.	Other: None - Standard of Care
Cirrhosis without Hepatocellular Carcinoma		Subjects with only cirrhosis.	Other: None - Standard of Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
None - Standard of Care	Other		Cirrhosis without Hepatocellular Carcinoma Hepatocellular Carcinoma with Cirrhosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Using next-generation sequencing methods to detect isomiRs across different HCC cohorts at all stages undergoing liver transplantation.		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with the diagnosis of HCC who are on the wait list for liver transplantation
Patients with the diagnosis of HCC who have been admitted to hospital, scheduled to undergo liver transplantation within the following 24 hours.
Age Range: 18 to 75 years old

Exclusion Criteria:

Patients with metastatic HCC and patients with the diagnosis of HCC who are not on the wait list for liver transplantation.
Patients older than 75 years old and younger than 18 years old.
Patients who are unable to consent.
Pregnant patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Hepatocellular Carcinoma Clinic Pre-Liver Transplant Clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Kim, M.D.	Annette C. & Harold C. Simmons Transplant Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baylor University Medical Center		Dallas	Texas	75246	United States

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided