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Completed

NCT Number: NCT02412579

Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor University Medical Center

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

None - Standard of Care

Other

Primary outcomes

  1. Using next-generation sequencing methods to detect isomiRs across different HCC cohorts at all stages undergoing liver transplantation.

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

Circulating MicroRNA Isoforms as Biomarkers in Hepatocellular Carcinoma and Associated Liver Transplantation

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2015
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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