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OpenTrials
Completed

NCT Number: NCT04720430

Blood Sample Collection for Experimental Blood Test to Track Liver Cancer

This study investigates if an experimental blood test can help predict how well cancer will remain under control with treatment. Ther experimental blood test involves measuring mircoRNAs. MicroRNAs are small molecules which help regulate how genes are expressed. This information may help researchers guide treatment for other patients in the future.

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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 and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Who can participate

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

Inclusion criteria

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Definite diagnosis of hepatocellular carcinoma established (by standard radiographic or histologic criteria)
  • Felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy

Exclusion criteria

  • Either active or recent solid organ cancer other than hepatocellur carcinoma (HCC) within the last 5 years, unless determined by transplant hepatology team not to represent contra-indication to liver transplantation
  • Contra-indication to LRT (as assessed by interventional radiologist, for example severe thrombocytopenia, severe vascular disease precluding access, etc)
  • History of prior liver transplantation
  • Active or prior systemic therapy for HCC

Treatment and study plan

Primary outcomes

  1. Patient Clinical Status - Liver Transplant

    Time frame: At study completion, up to 12 months

    Undergoing liver transplant

  2. Patient Clinical Status - Death

    Time frame: At study completion, up to 12 months

    Will assess the following: death

  3. Patient Clinical Status - Candidacy

    Time frame: At study completion, up to 12 months

    No longer candidate for transplantation for reasons other than tumor progression

  4. Patient Clinical Status

    Time frame: At study completion, up to 12 months

    No longer candidate for transplantation due to tumor progression despite loco-regional therapy efforts

  5. Incidence of "Wait List Drop Off"

    Time frame: At study completion, up to 12 months

    Will be estimated and presented with a Clopper-Pearson exact binomial confidence interval

Secondary outcomes

  1. Time to "Wait List Drop Off"

    Time frame: Up to 12 months

    Cox proportinal hazards modeling will be used to investigate the associations of each micro ribonucleic acid (miRNO) with time to "wait list drop off"

  2. Clinical Status of the subset of patients successfully reaching liver transplant

    Time frame: At 1 year after transplantation

    Logistic regression modeling will be used to investigate the correlation of each miRNA with clincial status (alive without recurrence vs. recurrence or death) within one year of transplant will be cinducted in the subset of those undergoing transplant. The p-values will be adjusted for false discovery rate inflation by the methods of Benjamni & Hochberg (1995) for both secondary analyses, respectively

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Circulating MicroRNA Levels as a Predictor of Successful Bridging or Down-Staging Loco-Regional Therapy (LRT) to Liver Transplantation for Patients With Hepatocellular Carcinoma (HCC)

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Apr 29, 2025

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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