Clinical trial NCT05935189: Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens
Official title: Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens for Genetic and Histologic Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: Nikomed Medical Center
Sponsor class: NETWORK
First posted: 2023-07-07
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of individuals from Armenian descent who have a biopsy-confirmed diagnosis of hepatocellular carcinoma.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Failure to obtain informed consent

Primary outcomes:
measure: Creation of a registry
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Nikomed Medical Center
Study officials:
affiliation: Nikomed Medical Center
name: Hasmik Ghazinian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.