Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation

NCT ID: NCT02412579

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2022-03-17

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hepatocellular Carcinoma with Cirrhosis

Subjects with hepatocellular carcinoma and cirrhosis.

None - Standard of Care

Intervention Type OTHER

Cirrhosis without Hepatocellular Carcinoma

Subjects with only cirrhosis.

None - Standard of Care

Intervention Type OTHER

Interventions

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None - Standard of Care

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Annette C. & Harold C. Simmons Transplant Institute

Locations

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Baylor University Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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014-121

Identifier Type: -

Identifier Source: org_study_id

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