Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens

Recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT05935189
• Lead Sponsor: Nikomed Medical Center

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

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 Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-28
• Last Update Submitted: 2023-06-28
• Study Start: 2023-07-01
• Study First Posted: 2023-07-07
• Last Update Posted: 2023-07-07
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients with biopsy-confirmed diagnosis of HCC
• Armenian descent
• Having given their signed Informed consent

Exclusion Criteria

• Failure to obtain informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nikomed Medical Center; 🇦🇲 Yerevan, Armenia