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TIR-HCC: Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens

Sponsor
Nikomed Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05935189
Collaborator
(none)
500
Enrollment
1
Location
60
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of the study is to establish a cancer registry to facilitate research and assist in the identification of additional risk factors for hepatocellular carcinoma. The main objectives are:

  1. provide a mechanism to store the information about subjects with hepatocellular carcinoma

  2. use of tissue samples for translational/further research purposes

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Establishment of a Tissue Registry for Hepatocellular Carcinoma biopsy specimens for genetic and histologic research (TIR-HCC) is a project aimed at addressing the high incidence rates of primary liver cancer in Armenia. This initiative seeks to establish a cancer registry to support research efforts and identify additional risk factors associated with hepatocellular carcinoma (HCC).

    The study will involve patients of Armenian descent who exhibit clinical, biochemical, and imaging evidence of hepatocellular carcinoma. Data collection will include tissue and blood samples, which will undergo histologic and genetic analyses. Additionally, relevant clinical history, laboratory results, imaging findings, and gut microbiota profiles will be collected.

    To ensure a comprehensive dataset, samples will be collected from eight institutions in Armenia. The project aims to accumulate data from a total of 500 patients, providing a substantial pool for research and analysis.

    By establishing the TIR-HCC registry, researchers hope to contribute to the understanding of hepatocellular carcinoma and potentially identify new risk factors associated with the disease. The collected data will aid in advancing knowledge of HCC and guide future strategies for prevention, early detection, and treatment.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens for Genetic and Histologic Research
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Jul 1, 2028
    Anticipated Study Completion Date :
    Jul 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Creation of a registry [5 year]

      The primary outcome of this study is to provide a mechanism to store the information about subjects with hepatocellular carcinoma. The outcome will be measured by the number of patients involved in the registry, measured by absolute numbers. The target number is 500 patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with biopsy-confirmed diagnosis of HCC

    • Armenian descent

    • Having given their signed Informed consent

    Exclusion Criteria:
    • Failure to obtain informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nikomed Medical Center Yerevan Armenia

    Sponsors and Collaborators

    • Nikomed Medical Center

    Investigators

    • Principal Investigator: Hasmik Ghazinian, MD, Nikomed Medical Center

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Nikomed Medical Center
    ClinicalTrials.gov Identifier:
    NCT05935189
    Other Study ID Numbers:
    • NMC-2301
    First Posted:
    Jul 7, 2023
    Last Update Posted:
    Jul 7, 2023
    Last Verified:
    Jun 1, 2023
    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 Jul 7, 2023