Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens

Hepatocellular Carcinoma Clinical Trial

— TIR-HCC  

Official title:

Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens for Genetic and Histologic Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935189
• Other study ID #: NMC-2301
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: July 1, 2028

Study information

• Verified date: June 2023
• Source: Nikomed Medical Center
• Contact: Tigran Aghabekyan
• Phone: 99750721
• Email: tigran1999[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with biopsy-confirmed diagnosis of HCC

• Armenian descent

• Having given their signed Informed consent

Exclusion Criteria:

• Failure to obtain informed consent

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
Armenia	Nikomed Medical Center	Yerevan

Sponsors (1)

Lead Sponsor	Collaborator
Nikomed Medical Center

Country where clinical trial is conducted

Armenia, 

References & Publications (1)

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of a registry	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.	5 year

External Links

•   Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660