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Blood Sample Collection for Experimental Blood Test to Track Liver Cancer

Sponsor
Thomas Jefferson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04720430
Collaborator
(none)
30
Enrollment
1
Location
49
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official 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)
    Actual Study Start Date :
    Dec 3, 2019
    Anticipated Primary Completion Date :
    Nov 9, 2023
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Patient Clinical Status - Liver Transplant [At study completion, up to 12 months]

      Undergoing liver transplant

    2. Patient Clinical Status - Death [At study completion, up to 12 months]

      Will assess the following: death

    3. Patient Clinical Status - Candidacy [At study completion, up to 12 months]

      No longer candidate for transplantation for reasons other than tumor progression

    4. Patient Clinical Status [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" [At study completion, up to 12 months]

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

    Secondary Outcome Measures

    1. Time to "Wait List Drop Off" [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Thomas Jefferson University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT04720430
    Other Study ID Numbers:
    • 19D.737
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Aug 16, 2022